BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY S ANTI-HCV REAGENT KIT

    MDR report key: 11986180 · Received June 11, 2021

    Report

    Report Number
    3002809144-2021-00372
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    May 4, 2021
    Report Date
    July 12, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    QHM
    UDI-DI
    00380740117191
    PMA / PMN Number
    200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE ALINITY S ANTI-HCV REAGENT LOT 22802BE00 IDENTIFIED NORMAL COMPLAINT ACTIVITY. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. INHOUSE TESTING DETERMINED THAT THE SENSITIVITY PERFORMANCE IS NOT NEGATIVELY IMPACTED. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. THE PERFORMANCE OF THE LIKELY CAUSE LOT WAS INVESTIGATED BY COMPLETING A REVIEW FOR NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES AND DEVIATIONS RELATED TO THE LIKELY CAUSE LOT. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED WITH ALINITY S ANTI-HCV REAGENT LOT 22802BE00.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT IDENTIFIER SIDS: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER IS PERFORMING A CLINICAL TRIAL ON THE ALINITY S ANTI-HCV II ASSAY PROCESSED ON ANOTHER ALINITY S COMPARING TO THE CURRENT ON-MARKET ALINITY S ANTI-HCV ASSAY (PROCESSED ON THIS ALINITY S. DISCREPANT RESULTS PROVIDED: (B)(6). NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880514 ALINITY S ANTI-HCV REAGENT KIT HEPATITIS C VIRUS ENCODED ANTIGENS (RECOMBINANT C100-3, HCR43) QHM ABBOTT GMBH 22802BE00 00380740117191

    Patients

    Seq Age Sex Outcome Treatment
    1 ALNTY S SYSTEM, 06P16-01, AS1235, AS1238| ALNTY S SYSTEM, 06P16-01, AS1235, AS1238