BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABS 2000

    MDR report key: 910314 · Received September 12, 2007

    Report

    Report Number
    1034569-2007-00223
    Event Type
    Malfunction
    Date Received
    September 12, 2007
    Date of Event
    August 16, 2007
    Report Date
    September 11, 2007
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK960019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE INSTRUMENT RESULTS FILES CONFIRMED THE CUSTOMER'S RESULTS. TESTING OF IN-HOUSE DONOR SAMPLES OF VARIOUS RH PHENOTYPES, INCLUDING WEAK D CELLS, ON AN IN-HOUSE ABS2000 AND IN HA, USING RETENTION ANTI-D SERIES 4, LOT 504692, AND ANTI-D SERIES 5, LOT 505546 RESULTED IN EXPECTED REACTIVITY. THE RETURNED SAMPLES WERE TESTED WITH RETENTION ANTI-D SERIES 4, LOT 504692, AND ANTI-D SERIES 5, LOT 505546, ON AN IN-HOUSE ABS2000. THE SAMPLES TYPED AS O, RH-NEGATIVE; ONE SAMPLE WAS SEVERELY HEMOLYZED. THE SAMPLES WERE TESTED IN HA WITH RETENTION ANTI-D SERIES 4, LOT 504692, AND ANTI-D SERIES 5, LOT 505546, AND WITH OTHER MANUFACTURERS' ANTI-D BLOOD GROUPING REAGENTS. THE SAMPLES EXHIBITED NO REACTIVITY WITH ALL ANTI-D REAGENTS TESTED. THE CUSTOMER'S TYPING OF O, RH-NEGATIVE WAS CONFIRMED. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN RH DISCREPANCY ON THE ABS2000. A O RH NEGATIVE PATIENT WAS REPORTED AS RH POSITIVE BY THE ABS 2000. THE PATIENT WAS TESTED IN DUPLICATE ON THE ABS 2000; ONE SAMPLE WAS REPORTED AS O RH POSITIVE AND THE OTHER SAMPLE WAS NTD. A REDRAW OF THE SAMPLE WAS TESTED ON THE SAME DAY AND RESULTED AS O RH NEGATIVE. THE CUSTOMER PERFORMED TUBE TESTING WITH THE SAME REAGENTS USED ON THE INSTRUMENT; RESULTS WERE RH NEGATIVE.

    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 80 YR