BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0.8% RESOLVE PANEL C

    MDR report key: 1464048 · Received August 24, 2009

    Report

    Report Number
    2250051-2009-00261
    Event Type
    Injury
    Date Received
    August 24, 2009
    Date of Event
    July 16, 2009
    Report Date
    August 24, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT WAS RECEIVED POST EXPIRATION OF PRODUCT. BATCH REVIEW WAS PERFORMED AND ALL IN-PROCESS AND QA RELEASE TESTING WAS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT VRC129 DID NOT IDENTIFY ANTIBODIES IN A PT WHO WAS LATER CONFIRMED TO HAVE ANTI-C, E, CW, AND ANTI-KELL PRESENT IN THE PLASMA. IN 2009, THE PT'S ANTIBODY SCREEN WAS OBSERVED TO BE POSITIVE. THE CUSTOMER TESTED THE SAMPLE WITH THE PANEL AND DID NOT IDENTIFY SPECIFICITY. BASED ON THESE RESULTS, THE CUSTOMER CROSSMATCHED TWO DONOR UNITS BY A FULL CROSS MATCH IN GEL AND THESE TWO COMPATIBLE UNITS WERE TRANSFUSED. A TRANSFUSION REACTION OCCURRED. OCD'S MEDICAL DIRECTOR HAS CLASSIFIED THIS AS A SERIOUS INJURY. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% RESOLVE PANEL C REAGENT RED BLOOD CELLS MWN ORTHO-CLINICAL DIAGNOSTICS VRC129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other