BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN

    MDR report key: 779141 · Received August 30, 2006

    Report

    Report Number
    1034569-2006-00092
    Event Type
    Malfunction
    Date Received
    August 30, 2006
    Date of Event
    July 31, 2006
    Report Date
    August 30, 2006
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    102152
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDICAL ACTION WAS TAKEN AS A RESULT OF THE UNEXPECTED POSITIVE REACTIONS. INERT IN-HOUSE DONOR SAMPLES WERE TESTED WITH RETENTION CRRS, LOT X142, USING RETENTION CRRIC, LOTS 221903 AND 221904. NO UNEXPECTED REACTIONS WERE OBSERVED. ONLY CRRIC, LOT 221094 WAS RETURNED FOR INVESTIGATION TESTING. INERT IN-HOUSE DONOR SAMPLES WERE TESTED WITH RETENTION CRRS, LOT X142 AND RETURNED CRRIC, LOT 221094. FUZZY REACTIONS WITH A REDDISH BACKGROUND WERE OBSERVED. THE UNEXPECTED APPEARANCE OF THE REACTIONS WERE CAUSED BY THE HEMOLYSIS (2+) PRESENT IN THE RETURNED CRRIC. THE DIRECTION CIRCULAR STATES "CAPTURE R READY INDICATOR CELLS SHOULD NOT BE USED IF THE RED CELLS DARKEN FROM RED TO BROWN, IF THERE IS SIGNIFICANT HEMOLYSIS...". THE EVENT IS LIKELY DUE TO USER ERROR.

    Description of Event or Problem · 1

    INCONSISTENT REACTIONS INCLUDING UNEXPECTED NEGATIVE REACTIONS, WERE OBSERVED WHEN PERFORMING CAPTURE-R READY SCREEN (CRRS) ASSAY WITH CAPTURE-R READY INDICATOR CELLS (CRRIC). MANUAL TESTING WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN REAGENT RED BLOOD CELLS KSZ IMMUCOR * 22193

    Patients

    Seq Age Sex Outcome Treatment
    1