BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG CONFIRMATORY V.1 REAGENT KIT

    MDR report key: 13254971 · Received January 13, 2022

    Report

    Report Number
    3008344661-2022-00006
    Event Type
    Malfunction
    Date Received
    January 13, 2022
    Date of Event
    December 17, 2021
    Report Date
    June 9, 2022
    Manufacturer
    ABBOTT IRELAND
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO H.6. MEDICAL DEVICE PROBLEM CODE, IS UPDATED FROM A090804 TO THE CORRECT CODE OF A090809. UPDATE TO H.6. MEDICAL DEVICE PROBLEM CODE, IS UPDATED FROM A090804 TO THE CORRECT CODE OF A090809.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT LIST 8P09, THAT HAS A SIMILAR US PRODUCT DISTRIBUTED IN THE US, LIST 4P54. THE EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE PROVIDED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    INFORMATION PROVIDED BY THE CUSTOMER WAS REVIEWED AND SUPPORTS THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE LOT SEARCH REVIEW DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE ISSUE OF FALSE POSITIVE RESULTS. THIS IS THE ONLY COMPLAINT FOR THE LOT FOR THIS ISSUE. THE TICKET TRENDING REVIEW OF COMPLAINT DATA FOR THE LIKELY CAUSE LIST NUMBER DID NOT IDENTIFY ANY TREND REGARDING COMMONALITIES FOR LOT NUMBER AND ISSUE. NO ADVERSE TREND WAS IDENTIFIED. A REVIEW IN THE CORRECTIVE AND PREVENTIVE ACTIONS SYSTEM DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LOT NUMBER AND THE CUSTOMER ISSUE. LABELLING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. TESTING ON THE COMPLAINT LOT WAS NOT PERFORMED AS THE LOT HAD EXPIRED BEFORE THE INVESTIGATION WAS CREATED. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE ACCOUNT OBSERVED A (B)(6) ALINITY I HBSAG RESULT ON A PATIENT WITH LYMPHOCYTIC LEUKEMIA. USING 2 PATIENT SAMPLES INCONSISTENT RESULTS OF WEAK (B)(6) AND (B)(6) RESULTS WERE GENERATED. ON (B)(6) 2021, SID (B)(6) ALINITY I HBSAG (B)(6), AND NEUTRALIZATION CONFIRMED (B)(6). ON (B)(6) 2021, SID (B)(6) ALINITY I HBSAG (B)(6), AND ANTI-HBS OF (B)(6), AND NEUTRALIZATION (B)(6). REPRODUCIBILITY TESTING WAS PERFORMED. SAMPLE (B)(6) 2021 ALINITY I HBSAG (B)(6), NEUTRALIZATION CONFIRMED (B)(6). SAMPLE (B)(6) 2021 ALINITY I HBSAG (B)(6) OF 0.00 IU/ML, NEUTRALIZATION (B)(6). HETEROPHILIC ANTIBODY BLOCKER SHOWED NO NON-SPECIFIC REACTION DUE TO HETEROPHILIC ANTIBODIES. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545589 ALINITY I HBSAG CONFIRMATORY V.1 REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND 23553FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY I HBSAG QUANT 120, 08P08-32, 28564FN00| ALNTY I HBSAG QUANT 120, 08P08-32, 28564FN00| ALNTY I HBSAG QUANT 120, 08P08-32, 28564FN00| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)