BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 960933 · Received August 11, 2006

    Report

    Report Number
    2250051-2006-00339
    Event Type
    Malfunction
    Date Received
    August 11, 2006
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    RETAIN TESTING BY ORTHO-CLINICAL DIAGNOSTICS INC. TO CONFIRM THE REACTIVITY OF THE ANTIGENS ON THE RED CELLS WAS SATISFACTORY. PER CUSTOMER: PRE AND POST SAMPLE WERE TESTED USING 6SS425 BECAUSE LOT 8SS421 WAS NO LONGER AVAILABLE. TESTING WAS PERFORMED IN GEL. BOTH SCREENS WERE NEGATIVE. PRE- AND POST DAT'S WERE NEGATIVE. IMMUCOR PANEL WAS ALSO NEGATIVE WITH PRE- AND POST SAMPLES. FULL CROSSMATCH WAS PERFORMED ON ALL FOUR UNITS TRANSFUSED. ONE UNIT REACTED 1+ WITH PRE-SAMPLE. ALL FOUR UNITS WERE COMPATIBLE WITH POST-SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * KSZ ORTHO-CLINICAL DIAGNOSTICS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1