BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANOSCREEN I & II

    MDR report key: 1056573 · Received June 9, 2008

    Report

    Report Number
    1034569-2008-00183
    Event Type
    Malfunction
    Date Received
    June 9, 2008
    Date of Event
    May 19, 2008
    Report Date
    June 5, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Removal / Correction Number
    FA 08-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PERFORMED A RETENTION INSPECTION ON 1 UNOPEN KIT OF PANOSCREEN LOT 14617; PRODUCTS APPEARED AS EXPECTED. THE RETENTION SAMPLE AND RETURNED PRODUCT WERE SUBMITTED FOR CULTURE. PERFORMED A RETURNED PRODUCT INSPECTION ON 5 UNOPEN KITS OF PANOSCREEN LOT 14617. PRODUCTS APPEARED AS EXPECTED. A RETENTION VIAL WAS GRAM STAINED AND PLATED ON SDA. GROWTH WAS OBSERVED ON SDA PLATES AND OBSERVED MICROSCOPICALLY DURING THE EXAMINATION OF THE GRAM STAIN SLIDES. THE GROWTH WAS IDENTIFIED AS CANDIDA (YEAST). 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 UNEXPECTED COLOR IN CELL II OF PANOSCREEN II, LOT# 14617. CELLS APPEARED DARK IN COLOR IN ALL FIVE SETS RECEIVED IN THE SAME SHIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANOSCREEN I & II REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. 14617

    Patients

    Seq Age Sex Outcome Treatment
    1