BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY S HBSAG REAGENT KIT

    MDR report key: 17221706 · Received June 28, 2023

    Report

    Report Number
    3008344661-2023-00119
    Event Type
    Injury
    Date Received
    June 28, 2023
    Date of Event
    June 4, 2023
    Report Date
    June 28, 2023
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    QHM
    UDI-DI
    00380740136819
    PMA / PMN Number
    BL 125674
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THE COMPLAINT INVESTIGATION FOR FALSE REACTIVE ALINITY S HBSAG RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. TRENDING REVIEW DETERMINED NO RELATED TREND FOR THE ISSUE AND THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT NUMBER, 42375FN00, AND COMPLAINT ISSUE. THE OVERALL REACTIVE RATES OF LIST NUMBER 06P02-60, LOT 42375FN00, ACROSS CORE, APPLICABLE PEER SITES, AND ACROSS A WHOLE BLOOD AND PLASMA SCREENING MONITORING GROUP WERE COLLECTED AND ASSESSED. ACROSS THE WHOLE BLOOD AND PLASMA MONITORING GROUP, THE INITIAL REACTIVE RATE (IRR), REPEAT REACTIVE RATE (RRR), AND SPECIFICITY (ASSUMING ZERO PREVALENCE) OBSERVED FOR LOT 42375FN00 IS WITHIN PRODUCT REQUIREMENTS, WITHIN PACKAGE INSERT REPRESENTATIVE DATA, AND COMPARABLE TO OTHER LOTS ANALYZED IN THE COMPARISON: LOT 42375FN00: (B)(4). LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, ALINITY S HBSAG, LOT NUMBER 42375FN00, IS PERFORMING AS INTENDED AND NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S HBSAG RESULTS FOR A CADAVERIC SAMPLE. THE FOLLOWING DATA WAS PROVIDED (>/=1.00 S/CO IS REACTIVE): SAMPLE ID (B)(6), 40-YEAR-OLD FEMALE, INITIAL RESULT, ON (B)(6) 2023,WAS 1.41, REPEATS WERE 1.42 AND 1.41 S/CO. THE SAMPLE WAS NEGATIVE WHEN TESTED WITH NAT. THE ASSOCIATED TISSUES FROM THIS DONOR WERE DISCARDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151399 ALINITY S HBSAG REAGENT KIT ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (MOUSE MONOCLONAL IGG AND IGM) QHM ABBOTT IRELAND DIAGNOSTICS DIVISION 42375FN00 00380740136819

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Disability ALNTY S SYSTEM, 06P16-01, AS1346