BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 4085294 · Received September 12, 2014

    Report

    Report Number
    1034569-2014-00164
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 13, 2014
    Report Date
    September 12, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PI LAB CONFIRMED THE REACTIVITY OF THE S ANTIGEN ON OUR RETENTION CAPTURE-R READY-SCREEN (3) PLATE USING RETENTION CAPTURE-R READY INDICATOR RED CELLS, LOT 221209. CONTROLS PERFORMED AS EXPECTED. ALL S POSITIVE TEST WELLS EXHIBITED THE EXPECTED REACTIVITY. RETENTION PERFORMED AS EXPECTED. THE CUSTOMER'S SUBMITTED SAMPLE WAS RECEIVED AFTER THE EXPIRATION DATE OF THE IMPLICATED PRODUCT. NO TESTING WAS PERFORMED IN THE PRODUCT INVESTIGATION LABORATORY USING THE RETURNED SAMPLE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY SCREEN 3 (CRRS3) ON A GALILEO ECHO. TESTING WAS PERFORMED USING CUSTOMER USING CAPTURE-R READY INDICATOR RED CELLS (CRRIC) LOT 221209.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565695 CAPTURE-R READY INDICATOR RED CELLS ANTI-IGG-COATED INDICATOR RED CELLS FOR USE IN SOLID PHASE ASSAYS KSZ IMMUCOR, INC. 221209

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR