BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN 4

    MDR report key: 1518391 · Received October 30, 2009

    Report

    Report Number
    1034569-2009-00375
    Event Type
    Malfunction
    Date Received
    October 30, 2009
    Date of Event
    September 30, 2009
    Report Date
    October 28, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    WE TESTED RETURNED SAMPLES ON 2 IN-HOUSE GALILEO INSTRUMENTS USING RETENTION CRRS4, LOT K229.SAMPLE 1 TESTED NEGATIVESAMPLE 2 TESTED NEGATIVESAMPLE 3 TESTED NEGATIVEA KNOWN ANTI-CW IN-HOUSE SAMPLE TESTED POSITIVE ON RETENTION CRRS4, LOT K229 ON BOTH INSTRUMENTS.TESTED SAMPLE MANUALLY IN TUBE TEST USING RETENTION PANOCELL-16.SAMPLE 1 WAS NEGATIVE AT ALL CONDITIONS WITH CELL 1 (CW NEG)SAMPLE 1 WAS -/+ AT 4°C, 1+ AT RT, (+) AT 37°C, 1+ AT ICT (POLYCL. AHG) AND (+) AT ICT (MONOCL. ANTI-IGG) WITH CELL 2 (CW POS)SAMPLE 2 WAS WAS NEGATIVE AT ALL CONDITIONS WITH CELL 1 (CW NEG)SAMPLE 2 WAS -/+ AT 4°C, (+) AT RT, 1+ AT 37°C, (+) AT ICT (POLYCL. AHG) AND (+) AT ICT (MONOCL. ANTI-IGG) WITH CELL 2 (CW POS)SAMPLE 3 WAS WAS NEGATIVE AT ALL CONDITIONS WITH CELL 1 (CW NEG).SAMPLE 3 WAS -/+ AT 4°C, -/+ AT RT, (+) AT 37°C, 1+ AT ICT (POLYCL. AHG) AND (+) AT ICT (MONOCL. ANTI-IGG) WITH CELL 2 (CW POS)

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONSWHEN TESTING SAMPLE CONTAINING ANTI-CW WITH CAPTURE-R READY-SCREEN4 (CRRS 4) ON THE GALILEO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN 4 REAGENT RED BLOOD CELLS KSZ IMMUCOR K229

    Patients

    Seq Age Sex Outcome Treatment
    1