BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 6057835 · Received October 26, 2016

    Report

    Report Number
    1034569-2016-00272
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    September 28, 2016
    Report Date
    October 26, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001454
    PMA / PMN Number
    102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REMOTE REVIEW OF CUSTOMER'S INSTRUMENT IMAGES: SAMPLE (B)(6) BATCH 50190 TESTED ON (B)(6) 2016. NEGATIVE REACTIONS AS EXPECTED FOR CELL 1, VISUALLY NEGATIVE. UNEXPECTED NEGATIVE REACTIONS FOR CELLS 2 AND 3, VISUALLY NEGATIVE CONTROLS REACTED AS EXPECTED PI LAB CONFIRMED THE REACTIVITY OF THE E ANTIGEN ON CELL 2 OF RETENTION CAPTURE-R READY SCREEN (3) PLATES LOT R770 USING RETENTION CAPTURE-R INDICATOR CELLS LOT 221714 AND RETENTION ANTI-E LOT TN0034. CONTROLS PERFORMED AS EXPECTED AND CELL 2 WAS 4+ POSITIVE. RETENTION PRODUCT PERFORMED AS EXPECTED. PI LAB CONFIRMED THE REACTIVITY OF THE K ANTIGEN ON CELL 3 OF RETENTION CAPTURE-R READY SCREEN (3) PLATES LOT R770 USING RETENTION CAPTURE-R INDICATOR CELLS LOT 221714 AND RETENTION ANTI-K LOT DL18585A. CONTROLS PERFORMED AS EXPECTED AND CELL 3 WAS 3+ POSITIVE. RETENTION PRODUCT PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED (B)(6) RESULT WHEN TESTING A PATIENT SAMPLE USING CAPTURE-R READY-SCREEN (3) (CRRS 3) ON THE GALILEO ECHO M00810. THE PATIENT HAS A HISTORY OF ANTI-E AND ANTI-K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710123 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R770 10888234001454

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR