BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 811207 · Received January 19, 2007

    Report

    Report Number
    1823260-2007-00555
    Event Type
    Malfunction
    Date Received
    January 19, 2007
    Date of Event
    December 31, 2006
    Report Date
    January 18, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    k961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL RESULTS FOR TWO PT CK-MBS WERE <0.1 NG/ML. WHEN REPEATED, THE RESULTS WERE 2.3 AND 3.3 NG/ML. THE INCORRECT RESULTS WERE NOT USED TO GUIDE THERAPY. THE FIELD SERVICE REP FOUND THE SAMPLE SYSTEM WAS MISALIGNED AND REPAIRED THE INSTRUMENT BY ADJUSTING THE SAMPLE ROLLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK CLINICAL IMMUNOASSAY ANALYZER-JJE JJE ROCHE DIAGNOSTICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA