BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HCV REAGENT KIT

    MDR report key: 22408964 · Received July 6, 2025

    Report

    Report Number
    3002809144-2025-00215
    Event Type
    Malfunction
    Date Received
    July 6, 2025
    Date of Event
    June 9, 2025
    Report Date
    August 13, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZO
    UDI-DI
    00380740169213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P06 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08P05, WITH 510K/PMA/BLA NUMBER P050042. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, A TICKET TRENDING REVIEW, A DEVICE HISTORY RECORD REVIEW, A LABELING REVIEW, AND IN-HOUSE TESTING OF A RETAINED REAGENT KITS. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I ANTI-HCV ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 71200BE00. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 71200BE00 AND THE COMPLAINT ISSUE. IN-HOUSE TESTING OF A RETAINED REAGENT KITS OF THE COMPLAINT LOT WAS PERFORMED. ALL CONTROLS MET SPECIFICATIONS, AND NO FALSE NONREACTIVE RESULTS WERE OBTAINED, INDICATING THAT THE LOT PERFORMED AS EXPECTED. TESTING INCLUDED FIVE ADDITIONAL REPLICATES OF THE POSITIVE CONTROL AND ONE COMMERCIALLY AVAILABLE SEROCONVERSION PANEL (ZEPTOMETRIX HCV 9045). THE POSITIVE CONTROL WAS WITHIN SPECIFICATIONS. THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO THE TEST RESULTS PROVIDED BY ZEPTOMETRIX. REAGENT LOT 71200BE00 DETECTED THE SAME BLEEDS AS REACTIVE, WITH COMPARABLE S/CO VALUES FOR THE SEROCONVERSION PANEL. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I ANTI-HCV REAGENT, LOT NUMBER 71200BE00.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NONREACTIVE ALINITY I ANTI-HCV RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PATIENT. THE PATIENT HAD A PREVIOUSLY CONFIRMED POSITIVE ANTI-HCV RESULTS ON (B)(6) 2025. HOWEVER, ON (B)(6) 2025, A NEW TEST SHOWED A NONREACTIVE RESULT OF 0.98 S/CO. GIVEN THE PATIENT¿S KNOWN POSITIVE HISTORY, THE SAME SAMPLE WAS RETESTED AFTER RE-CENTRIFUGATION, YIELDING REACTIVE RESULTS. HCV CONFIRMATORY TESTING WAS PERFORMED AND GENERATED A POSITIVE RESULT. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, = 1.00 S/CO IS REACTIVE): (B)(6) 2025 SID (B)(6): ALINITY I ANTI-HCV INITIAL RESULT = 0.98 S/CO (NONREACTIVE). ALINITY I ANTI-HCV REPEAT RESULTS (POST RE-CENTRIFUGATION) = 1.05 S/CO (REACTIVE), 1.07 S/CO (REACTIVE). HCV CONFIRMATORY = POSITIVE (C1 = 0, C2 = +2, E2 = 0, NS3 = +2, NS4 = 0, NS5 = 0). ALINITY S ANTI-HCV RESULT = 72.35 S/CO (REACTIVE). HISTORICAL RESULTS: (B)(6) 2025: ALINITY I ANTI-HCV RESULT = 1.07 S/CO (REACTIVE). HCV CONFIRMATORY = POSITIVE (C1 = 0, C2 = +1, E2 = 0, NS3 = +1, NS4 = 0, NS5 = 0). (B)(6) 2025: ALINITY I ANTI-HCV RESULTS = 1.07 S/CO (REACTIVE), 1.11 S/CO (REACTIVE), 1.10 S/CO (REACTIVE). (B)(6) 2023: ALINITY I ANTI-HCV = 0.83 S/CO (NONREACTIVE); HBSAG = 0.42 S/CO (NONREACTIVE); ANTI-HBC = 7.51 S/CO (REACTIVE); ANTI-HBS = 70.44 MIU/ML (REACTIVE); HBEAG = 0.392 S/CO (NONREACTIVE); HBEAB = 0.11 S/CO (REACTIVE); HAVAB IGG = 12.24 S/CO (REACTIVE). UPDATE: ON 09JUN2025, ADDITIONAL INFORMATION WAS PROVIDED. A NEW SAMPLE FROM THE PATIENT WAS TESTED, YIELDING NONREACTIVE RESULTS. THE FOLLOWING DATA WAS PROVIDED: 09JUN2025 SID LB137359 (NEW DRAW): ALINITY I ANTI-HCV RESULTS FROM LOT# 71200BE00 = 0.97 S/CO (NONREACTIVE), 0.91 S/CO (NONREACTIVE) THE CUSTOMER STATED THAT THE PATIENT HAS BEEN UNDERGOING ANTIRETROVIRAL THERAPY SINCE 1998 (TRUVADA AND ETRAVIRINE). IN 2018, THE REGIMEN WAS CHANGED TO DOLUTEGRAVIR + EMTRICITABINE + TENOFOVIR ALAFENAMIDE, WITH THE PATIENT MAINTAINING AN UNDETECTABLE VIRAL LOAD. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NONREACTIVE ALINITY I ANTI-HCV RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PATIENT. THE PATIENT HAD A PREVIOUSLY CONFIRMED POSITIVE ANTI-HCV RESULTS ON (B)(6) 2025. HOWEVER, ON (B)(6) 2025, A NEW TEST SHOWED A NONREACTIVE RESULT OF 0.98 S/CO. GIVEN THE PATIENT¿S KNOWN POSITIVE HISTORY, THE SAME SAMPLE WAS RETESTED AFTER RE-CENTRIFUGATION, YIELDING REACTIVE RESULTS. HCV CONFIRMATORY TESTING WAS PERFORMED AND GENERATED A POSITIVE RESULT. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, = 1.00 S/CO IS REACTIVE): (B)(6) 2025 SID (B)(6): ALINITY I ANTI-HCV INITIAL RESULT = 0.98 S/CO (NONREACTIVE), ALINITY I ANTI-HCV REPEAT RESULTS (POST RE-CENTRIFUGATION) = 1.05 S/CO (REACTIVE), 1.07 S/CO (REACTIVE), HCV CONFIRMATORY = POSITIVE (C1 = 0, C2 = +2, E2 = 0, NS3 = +2, NS4 = 0, NS5 = 0), ALINITY S ANTI-HCV RESULT = 72.35 S/CO (REACTIVE). HISTORICAL RESULTS: (B)(6) 2025: ALINITY I ANTI-HCV RESULT = 1.07 S/CO (REACTIVE). HCV CONFIRMATORY = POSITIVE (C1 = 0, C2 = +1, E2 = 0, NS3 = +1, NS4 = 0, NS5 = 0). (B)(6) 2025: ALINITY I ANTI-HCV RESULTS = 1.07 S/CO (REACTIVE), 1.11 S/CO (REACTIVE), 1.10 S/CO (REACTIVE). (B)(6) 2023: ALINITY I ANTI-HCV = 0.83 S/CO (NONREACTIVE); HBSAG = 0.42 S/CO (NONREACTIVE); ANTI-HBC = 7.51 S/CO (REACTIVE); ANTI-HBS = 70.44 MIU/ML (REACTIVE); HBEAG = 0.392 S/CO (NONREACTIVE); HBEAB = 0.11 S/CO (REACTIVE); HAVAB IGG = 12.24 S/CO (REACTIVE). UPDATE: ON 09JUN2025, ADDITIONAL INFORMATION WAS PROVIDED. A NEW SAMPLE FROM THE PATIENT WAS TESTED, YIELDING NONREACTIVE RESULTS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025 SID (B)(6) (NEW DRAW): ALINITY I ANTI-HCV RESULTS FROM LOT# 71200BE00 = 0.97 S/CO (NONREACTIVE), 0.91 S/CO (NONREACTIVE). THE CUSTOMER STATED THAT THE PATIENT HAS BEEN UNDERGOING ANTIRETROVIRAL THERAPY SINCE 1998 (TRUVADA AND ETRAVIRINE). IN 2018, THE REGIMEN WAS CHANGED TO DOLUTEGRAVIR + EMTRICITABINE + TENOFOVIR ALAFENAMIDE, WITH THE PATIENT MAINTAINING AN UNDETECTABLE VIRAL LOAD. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2767956 ALINITY I ANTI-HCV REAGENT KIT ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS MZO ABBOTT GMBH 71200BE00 00380740169213

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)