BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 5134658 · Received October 8, 2015

    Report

    Report Number
    1034569-2015-00149
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Date of Event
    September 8, 2015
    Report Date
    October 6, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/5045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SEROLOGICAL EVALUATION. RETENTION TESTING: THE 3_CELL ASSAY WAS PERFORMED ON (B)(4) USING RETENTION STRIPES OF CRRS (3) PLATES LOT E169 WITH A KNOWN ANTI-KP(A) POSITIVE SAMPLE AND A KNOWN ANTI-KP(A) NEGATIVE IN-HOUSE SAMPLE. THE REACTION PATTERN IS DESCRIBED IN THE FOLLOWING: ANTI-KP(A) POSITIVE SAMPLE: (B)(6). THE ANTI-KP (A) NEGATIVE SAMPLE REACTED NEGATIVE FOR ALL THREE CELLS. THE RETENTION PRODUCT PERFORMED AS EXPECTED. RETURNED SAMPLE TESTING: WE RECEIVED 1 WHOLE BLOOD SAMPLE ID (B)(6). AFTER CENTRIFUGATION FOR 10 MINUTES AT 3.000 RPM, THE SAMPLE SHOWED A STRONG 4+ HEMOLYTIC CHARACTER. THE 3_CELL ASSAY WAS PERFORMED ON (B)(4) USING RETENTION STRIPES OF CRRS (3) PLATES LOT E169 WITH THE RECEIVED CUSTOMER SAMPLE. THE SAMPLE RESULTED INVALID. BASED ON THE HEMOLYTIC CHARACTER, WE DID NOT PERFORM ADDITIONAL TESTING OF THE CUSTOMER SAMPLE

    Description of Event or Problem · 1

    ON (B)(6) 2015, A CUSTOMER REPORTING AN UNEXPECTED NEGATIVE RESULT ON AN ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN 3 (CRRS3) ON A GALILEO ECHO INSTRUMENT. THE SAMPLE CONTAINED AN ANTI-KPA, WHICH WAS NOT PICKED UP BY THE CRRS3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668541 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. E169

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR