BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABS2000

    MDR report key: 724255 · Received June 7, 2006

    Report

    Report Number
    1034569-2006-00021
    Event Type
    Other
    Date Received
    June 7, 2006
    Date of Event
    May 2, 2006
    Report Date
    May 31, 2006
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK960019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETENTION PRODUCTS PERFORMED AS EXPECTED. SERVICE WAS PERFROMED ON 5/4/06 AND THE INSTRUMENT WAS OPERATING WITHIN SPECIFICATIONS. A PREVENTIVE MAINTENANCE WAS PERFORMED.NO REPEAT TESTING WAS PERFORMED ON THE ABS2000 WITH EITHER THE PRE-OR POST TRANSFUSION SAMPLE. NO SAMPLES WERE RETURNED FOR INVESTIGATION.REVIEW OF THE RAW DATA FROM TESTING WITH THE ORIGINAL PATIENT SAMPLE DEMONSTRATES NEGATIVE INTERPRETATIONS, BUT INDICATES REACTIVITY BELOW THE THRESHOLD OF DETECTION. PMA 510K NUMBER IS BK960019

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED A TRANSFUSION REACTION. AN ANTIBODY SCREEN ON ABS 2000 WAS NEGATIVE. THE PATIENT WAS TRANSFUSED WITH A UNIT OF FYA+ BLOOD AND A UNIT OF FYA-BLOOD. RED BLOOD CELL UNITS WERE TRANSFUSED BASED ON THE NEGATIVE SCREENING RESULTS. A POST TRANSFUSION SAMPLE WAS DAT POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABS2000 AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other