BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN I AND II

    MDR report key: 2309228 · Received October 26, 2011

    Report

    Report Number
    1034569-2011-00168
    Event Type
    Malfunction
    Date Received
    October 26, 2011
    Date of Event
    September 27, 2011
    Report Date
    October 26, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE IMAGES SHOW THAT WELL B07 LOOKED EQUIVOCAL. WELL A07 LOOKED NEGATIVE. CELL 2 SHOULD HAVE BEEN POSITIVE. WELLS C02 AND D02 ARE BOTH STRONG POSITIVES. THE CUSTOMER RETESTED THE SAMPLE USING A NEW LOT OF PLATES AND THE SAME LOT OF INDICATOR CELLS. THE SAMPLE WAS POSITIVE WITH 2_CELL PLATES LOT X350. SWITCHING TO A NEW LOT OF PLATES RESOLVED THE ISSUE. CONFIRMED THE REACTIVITY OF THE K ANTIGEN ON RETENTIONS CAPTURE-R READY-SCREEN (2) (CRRS2), LOT X349 USING MANUAL CAPTURE WITH RETENTIONS CAPTURE-R READY INDICATOR RED CELLS (CRRIRC), LOT 221720, AND ANTI-K, LOT QC#1 (1:250 DILUTION). CONTROLS PERFORMED AS EXPECTED AND ALL REAGENT RED CELLS TESTED EXHIBITED THE EXPECTED REACTIVITY. CONFIRMED THE REACTIVITY OF THE K ANTIGEN ON RETURN CAPTURE-R READY-SCREEN (2) (CRRS2), LOT X349 USING MANUAL CAPTURE WITH RETENTIONS CAPTURE-R READY INDICATOR RED CELLS (CRRIRC), LOT 221720, AND ANTI-K, LOT QC#1 (1:250 DILUTION). CONTROLS PERFORMED AS EXPECTED AND ALL REAGENT RED CELLS TESTED EXHIBITED THE EXPECTED REACTIVITY. THIS INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY. THE CUSTOMER ISSUE WAS NOT REPRODUCED OR CONFIRMED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY SCREEN (CRRS) I AND II ON THE GALILEO INSTRUMENT. THE PATIENT HAS A KNOWN ANTI-KELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN I AND II REAGENT RED BLOOD CELL KSZ IMMUCOR, INC. X349

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR