BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN 4

    MDR report key: 2260770 · Received September 22, 2011

    Report

    Report Number
    1034569-2011-00144
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    August 24, 2011
    Report Date
    September 22, 2011
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAPTURE-R READY-SCREEN (4) ASSAY WAS PERFORMED MANUALLY USING CRIRC LOT (B)(4), EXP-DATE 2011-09-01, LISS LOT (B)(4), EXP-DATE 2011-12-17, CAPTURE-R POSITIVE CONTROL LOT (B)(4), EXP-DATE 2012-04-24, AND CAPTURE-R NEGATIVE CONTROL LOT (B)(4), EXP DATE 2012-04-15. FOR COMPARISON, STRIPES OF CRRS (4) LOT K293 AND TWO OTHER LOTS OF CRRS 4 WERE INVESTIGATED. CAPTURE-R CONTROLS, A NEGATIVE IN-HOUSE DONOR SAMPLE AND THE 1:2 DILUTED ANTI-CW MICRO REAGENT LOT(B)(4), USED AS POSITIVE CONTROL, EXHIBITED THE EXPECTED REACTIVITY WITH CLEAR NEGATIVE OR 4+ REACTIONS. CUSTOMER SUBMITTED PATIENT SAMPLE REACTED 1+ WITH THE CW POSITIVE CELL 1 OF ALL THREE LOTS OF CRRS 4 AND NEGATIVE WITH THE CW NEGATIVE CELLS 2-4 OF ALL THREE LOTS. THE CUSTOMER ISSUE WAS NOT REPRODUCED; THE ANTI-CW ANTIBODY IN THE SUBMITTED PATIENT SAMPLE WAS DETECTED ALTHOUGH IT IS OF VERY LOW CONCENTRATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WHEN TESTING A KNOWN ANTI-CW POSITIVE PATIENT SAMPLE WITH CAPTURE-R READY SCREEN 4 (CRRS 4). THE SAMPLE WAS RE-TESTED WITH CRRS 4 AND AGAIN RESULTED NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN 4 REAGENT RED BLOOD CELLS KSZ IMMUCOR K293

    Patients

    Seq Age Sex Outcome Treatment
    1