BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 5020873 · Received August 21, 2015

    Report

    Report Number
    1034569-2015-00117
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    July 24, 2015
    Report Date
    August 20, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSF
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS RESOLVED WHEN CUSTOMER SWITCHED TO A NEW VIAL OF CRRIC LOT 221434. ALL RESULTS WERE AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS ON CAPTURE-R READY ID WHEN TESTING ONE SAMPLE USING CAPTURE-R READY INDICATOR RED CELLS (CRRIC) LOT 221434. THE SAMPLE CONTAINED A KNOWN ANTI-E. THE ANTI-E WAS DETECTED WITH GEL CARD METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554585 CAPTURE-R READY INDICATOR RED CELLS ANTI-IGG-COATED INDICATOR RED CELLS FOR USE IN SOLID PHASE ASSAYS KSF IMMUCOR, INC. 221434

    Patients

    Seq Age Sex Outcome Treatment
    1