BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID

    MDR report key: 3833763 · Received May 27, 2014

    Report

    Report Number
    1034569-2014-00083
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO CUSTOMER PRODUCT OR PATIENT BLOOD SAMPLE WAS RETURNED TO IMMUCOR FOR IMMUCOR INVESTIGATION. IMMUCOR TECHNICAL SUPPORT USED REMOTE ACCESS METHOD TO ASSESS INSTRUMENT TEST WELL IMAGES ON (B)(4) 2014. IMMUCOR LABORATORY TESTED RETENTION PRODUCT ON (B)(4) 2014 WHICH PERFORMED AS EXPECTED. IMMUCOR FIELD SERVICE ENGINEER VISITED CUSTOMER SITE TO ASSESS INSTRUMENT ON (B)(4) 2014 AND CLEANED (AND RESEATED) THE WASH MANIFOLD. THE INSTRUMENT THEN SUBSEQUENTLY OPERATED SATISFACTORILY.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310241 CAPTURE-R READY-ID REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. ID211

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR