"*" indicates required fields Step 1 of 8 - Your Information 12% Your InformationName*Email* Employer*Address* Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country AfghanistanAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Sint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBrunei DarussalamBulgariaBurkina FasoBurundiCabo VerdeCambodiaCameroonCanadaCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos IslandsColombiaComorosCongoCongo, Democratic Republic of theCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzechiaCôte d'IvoireDenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEswatiniEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHoly SeeHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKorea, Democratic People's Republic ofKorea, Republic ofKuwaitKyrgyzstanLao People's Democratic RepublicLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacaoMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth MacedoniaNorthern Mariana IslandsNorwayOmanPakistanPalauPalestine, State ofPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRomaniaRussian FederationRwandaRéunionSaint BarthélemySaint Helena, Ascension and Tristan da CunhaSaint Kitts and NevisSaint LuciaSaint MartinSaint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSint MaartenSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia and the South Sandwich IslandsSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwedenSwitzerlandSyria Arab RepublicTaiwanTajikistanTanzania, the United Republic ofThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkmenistanTurks and Caicos IslandsTuvaluTürkiyeUS Minor Outlying IslandsUgandaUkraineUnited Arab EmiratesUnited KingdomUnited StatesUruguayUzbekistanVanuatuVenezuelaViet NamVirgin Islands, BritishVirgin Islands, U.S.Wallis and FutunaWestern SaharaYemenZambiaZimbabweÅland Islands Phone*FaxDo you have any customer enquiries, complaints, or repairs this month?* Yes No Select Month and year for “no customer contacts” reported.JanuaryFebruaryMarchAprilMayJuneJulyAugustSeptemberOctoberNovemberDecember20182019202020212022202320242025 General InformationIncident No.Date of Customer Contact* MM slash DD slash YYYY Reason For Registration Delay*The complaint came in after business hours.The system was unavailable at the time the issue was reported.I am a distributor and have already created a record of the complaint in another system.Date Entered In Business Partner Complaint System* MM slash DD slash YYYY Date Closed In Business Partner Complaint System MM slash DD slash YYYY Customer InformationCustomer Disclosure I am not allowed to disclose this information Customer Name*Customer Email* Customer Employer*Customer Address*Customer Address 2*Customer Town / City*Customer State / Province / Territory*Customer Country*United StatesAfghanistanAlbaniaAlgeriaAmerican SamoaAndorraAngolaAntigua and BarbudaArgentinaArmeniaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBoliviaBosnia and HerzegovinaBotswanaBrazilBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaColombiaComorosCongo, Democratic Republic of theCongo, Republic of theCosta RicaCôte d'IvoireCroatiaCubaCyprusCzech RepublicDenmarkDjiboutiDominicaDominican RepublicEast TimorEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFijiFinlandFranceGabonGambiaGeorgiaGermanyGhanaGreeceGreenlandGrenadaGuamGuatemalaGuineaGuinea-BissauGuyanaHaitiHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsraelItalyJamaicaJapanJordanKazakhstanKenyaKiribatiNorth KoreaSouth KoreaKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacedoniaMadagascarMadeiraMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMauritaniaMauritiusMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew ZealandNicaraguaNigerNigeriaNorwayNorthern Mariana IslandsOmanPakistanPalauPalestinePanamaPapua New GuineaParaguayPeruPhilippinesPolandPortugalPuerto RicoQatarRomaniaRussiaRwandaSaint Kitts and NevisSaint LuciaSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbia and MontenegroSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSpainSri LankaSudanSudan, SouthSurinameSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTogoTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTuvaluUgandaUkraineUnited Arab EmiratesUnited KingdomUnited StatesUruguayUzbekistanVanuatuVatican CityVenezuelaVietnamVirgin Islands, BritishVirgin Islands, U.S.YemenZambiaZimbabweCustomer Zip (Postal) CodeCustomer Phone*Customer FaxNumber Product InformationNo. of Product Issues 1 2 3 4 5 Product 1Product 1: Name*Product 1: LanguageDanishDutchEnglishEnglish (Canada)English (United Kingdom)FrenchFrench (France)GermanGreekItalianNorwegian, Bokmål (Norway)Polish (Poland)PortugueseRussian (Russia)SpanishSwedishTurkish (Turkey)Product 1: Information*Part / List No.Lot / Serial No.CLEW versionAnalyser versionUnit SetData mgmt version Add RemoveRequest a ReturnRGA No.Chargeable PO No.Quantity Add RemoveProduct 2Product 2: Name*Product 2: LanguageDanishDutchEnglishEnglish (Canada)English (United Kingdom)FrenchFrench (France)GermanGreekItalianNorwegian, Bokmål (Norway)Polish (Poland)PortugueseRussian (Russia)SpanishSwedishTurkish (Turkey)Product 2: Information*Part / List No.Lot / Serial No.CLEW versionAnalyser versionUnit SetData mgmt version Add RemoveRequest a ReturnRGA No.Chargeable PO No.Quantity Add RemoveProduct 3Product 3: Name*Product 3: LanguageDanishDutchEnglishEnglish (Canada)English (United Kingdom)FrenchFrench (France)GermanGreekItalianNorwegian, Bokmål (Norway)Polish (Poland)PortugueseRussian (Russia)SpanishSwedishTurkish (Turkey)Product 3: Information*Part / List No.Lot / Serial No.CLEW versionAnalyser versionUnit SetData mgmt version Add RemoveRequest a ReturnRGA No.Chargeable PO No.Quantity Add RemoveProduct 4Product 4: Name*Product 4: LanguageDanishDutchEnglishEnglish (Canada)English (United Kingdom)FrenchFrench (France)GermanGreekItalianNorwegian, Bokmål (Norway)Polish (Poland)PortugueseRussian (Russia)SpanishSwedishTurkish (Turkey)Product 4: Information*Part / List No.Lot / Serial No.CLEW versionAnalyser versionUnit SetData mgmt version Add RemoveRequest a ReturnRGA No.Chargeable PO No.Quantity Add RemoveProduct 5Product 5: Name*Product 5: LanguageDanishDutchEnglishEnglish (Canada)English (United Kingdom)FrenchFrench (France)GermanGreekItalianNorwegian, Bokmål (Norway)Polish (Poland)PortugueseRussian (Russia)SpanishSwedishTurkish (Turkey)Product 5: Information*Part / List No.Lot / Serial No.CLEW versionAnalyser versionUnit SetData mgmt version Add RemoveRequest a ReturnRGA No.Chargeable PO No.Quantity Add Remove Incident DescriptionProvide a clear concise problem statement describing the customer's enquiry, complaint, or repair. Refer to Q04.01.007. section 2.4, or Q04.01.001 as appropriate, for a detailed list of meaningful data to collect. The problem statement should address the following questions: What is happening with the system, the assay or the analyser? What is not happening that should be? Where is the issue being seen? Where is there no issue in the system (or what assays or tests, etc. are performing without issues)? When is the issue occurring? When is the issue NOT manifesting itself? How extensive is the issue (or how limited)? Is there specific data applicable to the situation? What were the expected results? Do the results fit the clinical picture? Incident DescriptionSupport SummaryAssociated documents used to provide guidance, troubleshoot or resolve the customer issue/concern, must be referenced. Include troubleshooting steps provided to customer Asked customer to perform ceramic cartridge Assisted customer with software update procedure Include if i-STAT equipment will be repaired or replaced.Summary Incident ReviewIs this an adverse event?*Any incident where the use of the product is suspected to have resulted in or been associated with an adverse outcome (death or serious injury) to a patient or user of the product. Yes No I don't know Comments*CommentsAdverse Event Evaluation Questions1. Were liquid quality control results outside the manufacturer's acceptable limits? Did the electronic simulator (internal or external) fail?* Yes No I don't know 2. Were patient results generated by the i-STAT unacceptable based on patient's clinical appearance?* Yes No I don't know 3. Were these suspect (unexpected) results released to a doctor or caregiver?* Yes No I don't know 4. Did the unacceptable results affect patient care? If yes, describe how patient care was affected.*Examples: A patient did not receive needed medical treatment based on i-STAT result A patient went to the hospital based on the i-STAT result and received treatment that may not have been necessary Patient underwent invasive surgical procedure due to i-STAT result Patient received change in medication or dosage based on i-STAT result Yes No I don't know 5 - Did the unacceptable results require the patient to receive medical or surgical treatment? If yes, describe.*Examples: A patient did not receive needed medical treatment based on i-STAT result A patient went to the hospital based on the i-STAT result and received treatment that may not have been necessary Patient underwent invasive surgical procedure due to i-STAT result Patient received change in medication or dosage based on i-STAT result Yes No I don't know Did the product malfunction?*The failure of the device to meet its performance specification; or otherwise perform as intended (for example an abnormal rate of suppressed results). Performance specifications include all claims made in the labelling for the device. If yes, describe in the comments section and submit form to APOC Technical Support within 15 days. Yes No I don't know CommentsIncident ReportWas the incident/adverse event/malfunction reported to a local regulatory agency?If yes, provide copies of any communication documentation e.g., forms. Yes No I don't know Comments ResolutionWas The Issue Resolved Through Your Troubleshooting Steps?* Yes No I don't know If no, please provide additional steps to be taken, if any. ReviewCustomer contact reports will be sent to Abbott Point of Care Technical Services by the 15th of the following month. {all_fields}List Add RemoveNameThis field is for validation purposes and should be left unchanged.