BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 2432931 · Received January 31, 2012

    Report

    Report Number
    1034569-2012-00013
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Date of Event
    January 4, 2012
    Report Date
    January 30, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE IMAGES FROM BATCH (B)(4) FOR SAMPLE (B)(4) SHOWS THAT CELL 2 IS WEAKLY POSITIVE, BUT CALL NEGATIVE BY THE INSTRUMENT. THE SAMPLE WAS RUN ON 3_CELL SCREEN LOT R192 USING CAPTURE-R READY INDICATOR RED CELLS (CRRIC) LOT 221751. THE SAMPLE WAS RE-TESTED ON (B)(6) 2012, USING 3_CELL SCREEN LOT R192 AND CRRIC LOT 221755. A REVIEW OF THE IMAGES FROM BATCH (B)(4) FOR SAMPLE (B)(4) SHOWS THAT CELL 2 IS 3+ POSITIVE. THE CELL LOOKS POSITIVE. A SECOND SAMPLE, ID (B)(4) WAS DRAWN AND TESTED ON (B)(6) 2012, ON BATCH (B)(4). A REVIEW OF THE IMAGES FROM BATCH (B)(4) FOR SAMPLE (B)(4) SHOWS THAT CELL 2 IS 4+ POSITIVE. THE CELL LOOKS POSITIVE. SWITCHING TO A NEW LOT OF CRRIC RESOLVED THE ISSUE. CRRIC LOT 221751 EXPIRED PRIOR TO INVESTIGATION. REVIEW OF RECORDS SHOWS RETENTION TESTING PERFORMED WHILE PRODUCT WAS IN DATE RESULTED AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ON THE 3_CELL SCREEN ON THE ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY INDICATOR RED CELLS ANTI-IGG-COATED INDICATOR RED CELLS FOR USE IN SOLID PHASE ASSAYS KSZ IMMUCOR, INC. 221751

    Patients

    Seq Age Sex Outcome Treatment
    1 48 MO