BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR CELLS

    MDR report key: 3383235 · Received October 3, 2013

    Report

    Report Number
    1034569-2013-00171
    Event Type
    Malfunction
    Date Received
    October 3, 2013
    Date of Event
    August 12, 2013
    Report Date
    October 3, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE IMAGE RESULT FILES SHOWED THE REACTIONS APPEARED AS REPORTED BY THE INSTRUMENT. CAPTURE-R READY INDICATOR RED CELLS, LOT 221026, EXPIRED PRIOR TO COMPLAINT BEING RECEIVED. PREVIOUS IN-HOUSE TESTING PERFORMED WITH THIS LOT RESULTED AS EXPECTED WITH IN-HOUSE DONORS. NO PRODUCT DEFICIENCY WAS IDENTIFIED. WE WERE UNABLE TO DETERMINE IF THE CUSTOMERS VIAL HAD BECOME COMPROMISED. EXPIRED.

    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-JKA AND ANTI-K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501153 CAPTURE-R READY INDICATOR CELLS ANTI-IGG COATED RED BLOOD CELLS KSZ IMMUCOR, INC. 221026

    Patients

    Seq Age Sex Outcome Treatment
    1 69