BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID

    MDR report key: 3812526 · Received May 15, 2014

    Report

    Report Number
    1034569-2014-00076
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 14, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC ACCESS METHOD ON (B)(4) 2014 TO ASSESS THE INSTRUMENT TEST WELL IMAGES. THE E ANTIGEN POSITIVE TEST WELL IMAGES ON ID211 WERE REPORTED AS NEGATIVE BY THE INSTRUMENT AND ALSO VISUALLY APPEARED AS NEGATIVE. NO CUSTOMER BLOOD SAMPLE OR SITE PRODUCT WAS RETURNED TO IMMUCOR FOR INVESTIGATION, HOWEVER, RETENTION PRODUCT WAS TESTED ON (B)(4) 2014 AND THE RETENTION PRODUCT PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291201 CAPTURE-R READY-ID REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. ID211

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR