BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN POOLED

    MDR report key: 1213223 · Received October 29, 2008

    Report

    Report Number
    1034569-2008-00521
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 27, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    TESTED IN-HOUSE DONOR SAMPLES, AND 1 ANTI-D STANDARDS KIT (0.05 IU/ML) WITH RETENTION CRRS-POOLED, LOT. CW144. ANTI-D( 0.05 IU/ML) SHOWED A 3+ POSITIVE REACTION. TESTED 52 IN-HOUSE DONOR SAMPLES AND ANTI-D STANDARDS KIT (0.025 IU/ML) WITH RETENTION CRRS-POOLED, LOT. CW144. ALL IN-HOUSE DONOR SAMPLES APPEARED AS EXPECTED NEGATIVE. ANTI-D (0.025 IU/ML) SHOWED SHOWED A 4+ POSITIVE REACTION. THE CUSTOMER DID NOT RETURN SAMPLES FOR INVESTIGATION TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE NEGATIVE RESULTS FOR SAMPLES TESTED WITH CAPTURE-R READY SCREEN (CRRS) POOLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN POOLED REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. CW144

    Patients

    Seq Age Sex Outcome Treatment
    1