BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION XPAND PLUS WITH HM

    MDR report key: 3914728 · Received July 4, 2014

    Report

    Report Number
    1226181-2014-00362
    Event Type
    Malfunction
    Date Received
    July 4, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 11, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE EVALUATED THE INSTRUMENT AND INSTRUMENT DATA AND DETERMINED THAT THE INSTRUMENT REQUIRED DECONTAMINATION. THE CAUSE OF THE DISCORDANT CTNI RESULTS WAS DUE TO INSTRUMENT CONTAMINATION. THE CSE PERFORMED AN INSTRUMENT DECONTAMINATION SERVICE AND SUCCESSFULLY RAN QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (CTNI) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON A DIMENSION XPAND PLUS WITH HM INSTRUMENT. THE DISCORDANT CTNI RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT, WHICH RESULTED LOWER. THE CORRECTED CTNI RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CTNI RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392588 DIMENSION XPAND PLUS WITH HM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION XPAND PLUS WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1