BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 5013346 · Received August 19, 2015

    Report

    Report Number
    1034569-2015-00115
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Date of Event
    July 21, 2015
    Report Date
    August 18, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT (CAPTURE-R READY INDICATOR RED CELL, LOT 221428) EXPIRED PRIOR TO REQUEST FOR INVESTIGATION. HOWEVER, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED. ALL SPECIFICATIONS WERE MET PRIOR TO RELEASE OF PRODUCT TO MARKET.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT UNEXPECTED NEGATIVE RESULTS WERE OBTAINED WITH THE ANTIBODY SCREENING ASSAY FOR A PATIENT SAMPLE CONTAINING AN ANTI-K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549969 CAPTURE-R READY INDICATOR RED CELLS ANTI-IGG COATED RED BLOOD CELLS KSZ IMMUCOR, INC. 221428

    Patients

    Seq Age Sex Outcome Treatment
    1