BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% RESOLVE PANEL A FOR GEL

    MDR report key: 2020233 · Received March 16, 2011

    Report

    Report Number
    2250051-2011-00051
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    October 25, 2010
    Report Date
    March 16, 2011
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS NOT ABLE TO PROVIDE LOT NUMBER OF PRODUCT, THEREFORE NO INVESTIGATION WAS ABLE TO BE PERFORMED. CUSTOMER MADE STATEMENT WHILE CONTACTING OCD REGARDING A SIMILAR ISSUE WITH VRA152. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SEVERAL MONTHS AGO, A PATIENT SAMPLE WITH ANTI-E DID NOT REACT WITH A LOT OF 0.8% RESOLVE PANEL A. CUSTOMER WAS NOT ABLE TO PROVIDE ADDITIONAL DETAILS OF THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1