BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R SELECT

    MDR report key: 2408575 · Received January 10, 2012

    Report

    Report Number
    1034569-2012-00003
    Event Type
    Malfunction
    Date Received
    January 10, 2012
    Date of Event
    December 13, 2011
    Report Date
    January 10, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RESULTS: CELL 2 (D NEGATIVE) APPEARED TO HAVE A FLAIR ON THE BUTTON SIMILAR TO THE UNEXPECTED POSITIVE REACTIONS. A HOLE WAS ALSO SEEN IN THE MONOLAYER COLOR CHECK. THE WEAK D ASSAY WAS REPEATED ON ECHO M00523 FOR SAMPLE (B)(6). THE SAMPLE RESULTED AS NEGATIVE, HOWEVER THERE WAS A HOLE SEEN IN THE MONOLAYER AND THE NEGATIVE BUTTON HAD A FLAIR SEEN ON THE UPPER LEFT SIDE. ON (B)(6) 2011, PERFORMED A WEAK D ON 4 KNOWN RH(D) NEGATIVE IN HOUSE DONORS AGAINST A KNOWN O NEGATIVE IN HOUSE DONOR, ON THE ECHO USING CAPTURE-R SELECT PLATES, LOT SC 188 AND CAPTURE-R READY INDICATOR RED CELLS, LOT 221751. CONTROLS PERFORMED AS EXPECTED AND ALL DONORS TESTED AS RH(D) NEGATIVE WITH THE WEAK D ASSAY WITH NO FLARES PRESENT IN THE CELL BUTTONS. RETENTION PRODUCTS PERFORMED AS EXPECTED. (B)(6) 2011, PERFORMED A WEAK D ON 4 KNOWN RH(D) NEGATIVE IN HOUSE DONORS AGAINST A KNOWN O NEGATIVE IN HOUSE DONOR, ON THE ECHO. USING THE CUSTOMER'S RETURNED CAPTURE-R SELECT PLATES, LOT SC188 AND RETENTION CAPTURE-R READY INDICATOR RED CELLS, LOT 221751. THERE WAS A CONTROL FAILURE WITH THE WEAK D ASSAY DUE TO THE POSITIVE CONTROL TESTING AS NEGATIVE WITH ALL DONORS. THERE WAS ALSO A SMALL FLARE PRESENT IN ONE OF THE CONTROL WELLS. THE WEAK D ASSAY WAS REPEATED AND ALL DONORS TESTED AS RH(D) NEGATIVE WITH NO FLARES PRESENT IN THE CELL BUTTONS. WE WERE ABLE TO REPRODUCE THE CUSTOMERS RESULTS. REVIEW OF THE MONOLAYER IMAGE CHECK ON RETENTION AND RETURNED PLATES REVEALED SMALL HOLES IN THE MONOLAYER MEMBRANE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED UNEXPECTED POSITIVE WEAK D RESULT WHEN TESTING A PATIENT SAMPLE ON WITH CAPTURE-R SELECT ON THE ECHO INSTRUMENT. REVIEW OF THE IMAGES SHOW HOLES IN THE MONOLAYER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R SELECT REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. SC188

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA