BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% RESOLVE PANEL A

    MDR report key: 2869238 · Received December 12, 2012

    Report

    Report Number
    2250051-2012-00298
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 12, 2012
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAINED TESTING AND A BATCH RECORD REVIEW. SATISFACTORY RESULTS WERE OBSERVED. COMPLAINT REVIEW WAS COMPLETED - THERE IS ONE SIMILAR COMPLAINT FOR LACK OF REACTIVITY WITH ANTI-E. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT NO REACTIVITY WAS OBSERVED WITH VRA175 (E+ CELLS) AND A PATIENT SAMPLE IN WHICH AN ANTI-E WAS LATER IDENTIFIED. THE PATIENT'S INITIAL ANTIBODY SCREEN TEST WAS POSITIVE; REACTIVITY OBSERVED WITH CELLS I AND II. ANTIBODY ID PERFORMED AND ANTI-C WAS IDENTIFIED. ADDITIONAL TESTING WAS LATER PERFORMED USING 0.8% RESOLVE PANEL B AND OTHER TESTING IN TUBE/LISS AND AN ANTI-E WAS ALSO IDENTIFIED. CUSTOMER THEN REPEATED TESTING WITH VRA175 WITH INCREASED INCUBATION (20MIN). CUSTOMER OBSERVED WEAK - 1+ REACTIVITY WITH THE HOMOZYGOUS E+ CELL. CUSTOMER ALSO TESTED DONOR # (B)(6) FOR THE REACTIVITY OF THE E ANTIGEN AND OBSERVED A 4+ REACTION. PATIENT RECEIVED ONE UNIT OF C NEGATIVE, E NEGATIVE, BLOOD. PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% RESOLVE PANEL A REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VRA175

    Patients

    Seq Age Sex Outcome Treatment
    1