BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CHEMISTRY IMMUNO GLOBULIN M_2 METHOD

    MDR report key: 1079539 · Received July 16, 2008

    Report

    Report Number
    2432235-2008-00078
    Event Type
    Other
    Date Received
    July 16, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 28, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K992662
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC FIELD SERVICE REP (FSE) WAS DISPATCHED TO THE ACCOUNT. ANALYSIS OF THE INSTRUMENT INDICATED THAT THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. THE CUSTOMER AGREED THAT THIS DISCORDANT RESULT WAS DUE TO A SINGLE INTERFERENCE OF UNK ORIGIN. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCREPANT IMMUNO GLOBULIN M (IGM) RESULT FOR ONE PT WAS GENERATED ON AN ADVIA CHEMISTRY SYSTEM. THE RESULT WAS REPORTED OUT BUT WAS QUESTIONED BY THE CLINICIAN WHO EXPECTED A MUCH HIGHER RESULT. UPON RERUN WITH A DILUTED SAMPLE, THE EXPECTED RESULT WAS OBTAINED. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT IGM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CHEMISTRY IMMUNO GLOBULIN M_2 METHOD CLINICAL CHEMISTRY IGM METHOD JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 107364

    Patients

    Seq Age Sex Outcome Treatment
    1