BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2840318 · Received November 20, 2012

    Report

    Report Number
    1226181-2012-00109
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 21, 2012
    Report Date
    October 22, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD
    Product Code
    MMI
    PMA / PMN Number
    K010061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT IS HETEROGENEOUS MODULE (HM) CONTAMINATION. THE SIEMENS HEALTHCARE DIAGNOSTICS TECHNICAL SERVICE CENTER (TSC) REPRESENTATIVE DIRECTED THE CUSTOMER TO APPROPRIATE DECONTAMINATION PROCEDURES AND PROBE MAINTENANCE WHICH RESOLVED THE PROBLEM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY ELEVATED TROPONIN I RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED AND A LOWER RESULT WAS OBTAINED AND REPORTED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED ON THE BASIS OF THE FALSELY ELEVATED RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1