BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY S ANTI-HCV REAGENT KIT

    MDR report key: 11938452 · Received June 4, 2021

    Report

    Report Number
    3002809144-2021-00353
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    April 30, 2021
    Report Date
    July 14, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    QHM
    UDI-DI
    00380740117191
    PMA / PMN Number
    200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF COMPLAINT ACTIVITY DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR LIKELY CAUSE LOT 21239BE00. TRENDING REPORT REVIEW FOR THE ALINITY S ANTI-HCV ASSAY DETERMINED THAT THERE ARE NO RELATED TRENDS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A RETAINED REAGENT KIT OF LOT NUMBER 21239BE00 WAS TESTED IN A SENSITIVITY SETUP, 112 REPLICATES OF TWO SENSITIVITY PANELS (ANTI-HCV PANEL A (CORE ONLY) AND ANTI-HCV PANEL B (NS3 ONLY) WERE TESTED. THE SENSITIVITY PANELS MET SPECIFICATIONS. NO FALSE NON-REACTIVE RESULTS WERE OBTAINED. ADDITIONALLY, TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS WERE TESTED. ALINITY S ANTI-HCV REAGENT LOT 21239BE00 DETECTED THE SAME FIRST BLEED AS REACTIVE COMPARED TO HISTORICAL RESULTS FOR ALINITY S ANTI-HCV. FURTHER, ADDITIONAL REPLICATES OF THE POSITIVE CONTROL WERE TESTED WHICH ALL MET SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY S ANTI-HCV REAGENT LOT 21239BE00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED (B)(6) ALINITY S ANTI-HCV RESULTS FOR MULTIPLE SAMPLES COMPARED TO ROCHE ANTI-HCV II ASSAY DURING A COMPARISON STUDY WITH A NEW ABBOTT ANTI-HCV II ASSAY. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2021 SID (B)(6) : ANTI-HCV (AS1300) RESULTS = (B)(6) . ANTI-HCV II (AS1242) RESULT = (B)(6) . NAT POOL OF 6 AND HCV IDT NAT BOTH (B)(6) .ROCHE ANTI-HCV II RESULTS = (B)(6) . (B)(6) 2021 SID (B)(6) : ANTI-HCV (AS1300) RESULTS = (B)(6). ANTI-HCV II (AS1242) RESULT = (B)(6) . NAT POOL OF 6 IS NEGATIVE AND HCV IDT NAT IS (B)(6) . ROCHE ANTI-HCV II RESULTS = (B)(6) (B)(6) 2021 SID (B)(6) : ANTI-HCV (AS1264) RESULTS = (B)(6) ANTI-HCV II (AS1242) RESULT = (B)(6) NAT POOL OF 6 IS NEGATIVE AND HCV IDT NAT IS (B)(6) . ROCHE ANTI-HCV II RESULTS = (B)(6) . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834126 ALINITY S ANTI-HCV REAGENT KIT HEPATITIS C VIRUS ENCODED ANTIGENS (RECOMBINANT C100-3, HCR43) QHM ABBOTT GMBH 21239BE00 00380740117191

    Patients

    Seq Age Sex Outcome Treatment
    1 ALNTY S SYSTEM, 06P16-01, (B)(6) | ALNTY S SYSTEM, 06P16-01, (B)(6)