BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2170509 · Received July 21, 2011

    Report

    Report Number
    1226181-2011-00049
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K963498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBABLE CAUSE OF THE FALSELY ELEVATED TROPONIN I RESULT IS MULTIPLE INSTRUMENT ISSUES. A SIEMENS HEALTHCARE DIAGNOSTICS FIELD SERVICE REPRESENTATIVE SERVICED THE INSTRUMENT. THE INSTRUMENT IS NOW 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 REPORTED TO THE PHYSICIAN. THE LABORATORY REPEATED THE SAMPLE AND A LOWER RESULT WAS OBTAINED. THE LABORATORY ISSUED A CORRECTED REPORT. A SECOND DRAW ALSO OBTAINED A LOW RESULT. ADDITIONAL REPEATS OF ORIGINAL SAMPLE WERE EITHER NEGATIVE OR LOW RESULTS. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ANY 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 CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS RXL MAX HM

    Patients

    Seq Age Sex Outcome Treatment
    1