BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID EXTEND I

    MDR report key: 3894061 · Received June 25, 2014

    Report

    Report Number
    1034569-2014-00102
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/5030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO CUSTOMER PRODUCT OR BLOOD SAMPLES WERE RETURNED TO IMMUCOR FOR IMMUCOR INVESTIGATION. IMMUCOR TECHNICAL SUPPORT USED REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS TEST WELL IMAGES ON CUSTOMER INSTRUMENT ON (B)(4) 2014.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID EXTEND I ON A GALILEO ECHO TESTED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371712 CAPTURE-R READY-ID EXTEND I REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. DP072

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR