BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1761269 · Received July 23, 2007

    Report

    Report Number
    1823260-2007-06392
    Event Type
    Malfunction
    Date Received
    July 23, 2007
    Date of Event
    July 1, 2007
    Report Date
    July 23, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCOUNT STATED THEY HAVE REPORTED DISCREPANT HCG RESULTS FROM THEIR ANALYZER AND GAVE THE FOLLOWING EXAMPLE. INITIAL HCG FOR A PATIENT SAMPLE WAS 1.66 MIU/ML. WHEN REPEATED ON A REDRAW THE RESULT WAS >10000 AND GAVE A RESULT OF 62636 WHEN DILUTED. WHEN THE ORIGINAL SAMPLE WAS REPEATED, THE RESULT WAS >10000. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE INCORRECT RESULT. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANT RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA