BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABS 2000

    MDR report key: 1003367 · Received February 28, 2008

    Report

    Report Number
    1034569-2008-00051
    Event Type
    Malfunction
    Date Received
    February 28, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 26, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK960019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    TESTED SAMPLES OF KNOWN ABO/RH WITH RETENTION ANTI-A, LOT 101678, ANTI-B, LOT 201567, ANTI-D, SERIES 4, LOT 504697, ANTI-D SERIES 5, LOT 505548, A1 AND B REFERENCELLS, LOTS 111633 AND 113633, RESPECTIVELY AND HDS, LOT OR144 ON AN IN-HOUSE ABS2000. THE EXPECTED REACTIVITY WAS OBSERVED IN ALL TESTING. THE CUSTOMER DID NOT RETURN PRODUCT OR SAMPLE FOR INVESTIGATION. A SERVICE CALL WAS MADE. TROUBLESHOOTING REVEALED ISSUES WITH THE WASHER AND PIPETTER. THE WASHER MANIFOLD WAS CLEANED, AND THE PIPETTER PROBE WAS ADJUSTED. THE SYRINGE PLUNGER WAS REPLACED. THE SYSTEM WAS OPERATIONAL FOLLOWING THE SERVICE CALL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ABO DISCREPANCY ON THE ABS2000 WITH A PATIENT SAMPLE. A B POSITIVE SAMPLE WAS REPORTED AS AB POSITIVE ON THE ABS2000. REVIEW OF RESULTS FILES DISPLAYED A POSITIVE REACTION WITH ANTI-A (SHOULD BE NEGATIVE) AND NEGATIVE REACTION WITH A1 CELLS (SHOULD BE POSITIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABS 2000 AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 DAY