BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN I AND II

    MDR report key: 2211188 · Received August 15, 2011

    Report

    Report Number
    1034569-2011-00108
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 12, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT RETURN SAMPLE FOR FURTHER SEROLOGICAL TESTING; THERE IS NO SPECIMEN LEFT FROM INITIAL TESTING. CANNOT CONFIRM WHETHER THE ANTI-KELL WAS PRESENT AT THE TIME THE INITIAL SAMPLE WAS TESTED. NO SAMPLE REMAINING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON A PATIENT SAMPLE TESTED WITH CAPTURE-R READY SCREEN (CRRS) I AND II. PATIENT SAMPLE WAS INITIALLY TESTED IN APRIL AND THE ANTIBODY SCREEN WAS NEGATIVE. A NEW SAMPLE FROM THE PATIENT WAS LATER TESTED AT THE HOSPITAL AND AN ANTI-KELL WAS IDENTIFIED. THERE IS NO SPECIMEN LEFT FROM INITIAL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN I AND II REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. X336

    Patients

    Seq Age Sex Outcome Treatment
    1