BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY I ANTI-HBC II REAGENT KIT

    MDR report key: 16219067 · Received January 20, 2023

    Report

    Report Number
    3002809144-2023-00047
    Event Type
    Injury
    Date Received
    January 20, 2023
    Date of Event
    November 29, 2022
    Report Date
    February 8, 2023
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOM
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    TRENDING REVIEW DETERMINED NO TREND FOR THE ISSUE FOR THE PRODUCT. HISTORICAL COMPLAINT REVIEW DETERMINED NO TREND IN COMPLAINT ACTIVITY FOR THE LOT NUMBER. DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE COMPLAINT LOT WAS PERFORMED, SHOWING THAT THE LOT GENERATES THE EXPECTED RESULTS. ALL SPECIFICATIONS WERE MET AND NO FALSE NON-REACTIVE RESULTS WERE OBTAINED, INDICATING THAT THE SENSITIVITY PERFORMANCE IS NOT NEGATIVELY IMPACTED. IN ADDITION, THE CLINICAL SENSITIVITY WAS EVALUATED BY TESTING TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS ON ONE INSTRUMENT. THE LOTS DETECTED THE SAME BLEEDS AS REACTIVE. BASED ON THESE DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE OF THE LOT IS NOT ADVERSELY AFFECTED. BASED ON THE INVESTIGATION, NO DEFICIENCY WITH ALINITY I ANTI-HBC II REAGENT LOT 40456BE00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER STATED THAT A FALSE NONREACTIVE ALINITY I ANTI-HBC II RESULT WAS GENERATED FOR A DONOR SAMPLE. THE FOLLOWING DATA WAS PROVIDED. (B)(4). (B)(6)2022. ALINITY I ANTI-HBC II RESULT: 0.96 S/CO (NONREACTIVE). (B)(4) (SAME SAMPLE THAWED AND RETESTED). (B)(6) 2022. ALINITY I ANTI-HBC II RESULT: 1.00 S/CO (REACTIVE). THERE WAS NO INFORMATION PROVIDED REGARDING WHETHER THE DONOR UNIT HAD BEEN TRANSFUSED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED ON FEBRUARY 1, 2023. IT WAS CONFIRMED THAT THE DONATION FROM DONOR SID (B)(4) WAS NOT TRANSFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105312 ALINITY I ANTI-HBC II REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT GMBH 40456BE00

    Patients

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