BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANOCELL-16

    MDR report key: 1061897 · Received June 20, 2008

    Report

    Report Number
    1034569-2008-00187
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 22, 2008
    Report Date
    June 9, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Removal / Correction Number
    FA 08-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PERFORMED A RETENTION INSPECTION ON PANOCELL-16, LOT 12584; EXP DATE: 5/30/08; CELLS #3 AND #16 CONTAINED PINK DILUENT EXHIBITING 2+ HEMOLYSIS WITH RED CELLS THAT APPEAR SLIGHTLY DARKER RED . CELL #1 AND REMAINING VIALS CONTAIN LIGHT PINK DILUENT EXHIBITING 1+ HEMOLYSIS WITH RED CELLS THAT APPEAR RED IN COLOR. GROWTH WAS OBSERVED ON THE RETENTION SAMPLES; YEAST WAS IDENTIFIED. THE PACKAGE INSERT ADVISES THE USER NOT TO USE THE PRODUCT IF THE CELLS DARKEN, SPONTANEOUSLY CLUMP, OR IF THERE IS SIGNIFICANT HEMOLYSIS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT CELLS # 3 AND 16 OF PANOCELL-16 LOT 12584 APPEAR VERY DARK IN COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANOCELL-16 REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. 12584

    Patients

    Seq Age Sex Outcome Treatment
    1