BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFERENCELLS

    MDR report key: 1462525 · Received September 4, 2009

    Report

    Report Number
    1034569-2009-00289
    Event Type
    Malfunction
    Date Received
    September 4, 2009
    Date of Event
    August 6, 2009
    Report Date
    September 1, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    107954 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVERSE GROUP TUBE TESTING OF IN-HOUSE DONOR SAMPLES WAS PERFORMED WITH ANTI-B SERIES 3 USING RETENTION B REFERENCE CELLS, LOT 113708. PRODUCTS PERFORMED AS EXPECTED.GROUP TESTING WAS PERFORMED WITH IN-HOUSE DONOR SAMPLES OF KNOWN ABO/RH TYPES USING RETENTION REFERENCELLS, LOT 110894 (A1 REFERENCELLS, LOT 111708, AND B REFERENCELLS, LOT 113708). ALL IN-HOUSE DONOR SAMPLES TYPED AS EXPECTED.THE CUSTOMER DID NOT RETURN SAMPLE FOR INVESTIGATION TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH B REFERENCELLS WHEN TESTING PATIENT SAMPLES THAT ARE GROUP A. SOME GROUP A PATIENTS ARE SHOWING WEAK REACTIVITY(1+ OR WEAK POSITIVE) WITH THE B CELLS. THE NEGATIVE AND WEAK REACTIONS ARE SEEN ON BOTH THE ECHO AND WITH MANUAL TUBE TESTING.NO TRANSFUSIONS OR ADVERSE REACTIONS OCCURRED, AS A RESULT OF THE UNEXPECTED NEGATIVE REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFERENCELLS BLOOD GROUPING REAGENT KSZ IMMUCOR 113708

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR