BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® XPAND WITH HM

    MDR report key: 2884165 · Received December 21, 2012

    Report

    Report Number
    1226181-2012-00171
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 26, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD
    Product Code
    JJE
    PMA / PMN Number
    K010061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND ANALYZED THE INSTRUMENT DATA. IT WAS DETERMINED THAT THE CAUSE OF THE DISCORDANT TACROLIMUS RESULTS IS UNKNOWN. THE FSE PERFORMED A PREVENTIVE MAINTENANCE (PM) OF THE INSTRUMENT. THE CUSTOMER DECLINED FURTHER SERVICE AS ALL OTHER ASSAYS WERE PERFORMING AS EXPECTED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS AND NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT FIVE DISCORDANT TACROLIMUS RESULTS WERE GENERATED BY THE DIMENSION XPAND WITH HM INTEGRATED CHEMISTRY SYSTEM. THE RESULTS WERE REPORTED AND THE NEPHROLOGISTS QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED AND THE CORRECT RESULTS WERE REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TACROLIMUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® XPAND WITH HM CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD DIMENSION® XPAND WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1