BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1591488 · Received February 1, 2010

    Report

    Report Number
    2517506-2010-00010
    Event Type
    Malfunction
    Date Received
    February 1, 2010
    Date of Event
    January 14, 2010
    Report Date
    January 21, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    MMI
    PMA / PMN Number
    K010313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED TROPONIN I RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS FILED THE ORIGINAL MDR (B)(4) 2010. NEW INFORMATION PROVIDED BY SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER (FSE) (B)(4) 2010: ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT WAS HM CHROME CONTAMINATION. THE SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE ACCOUNT AND PERFORMED REPAIRS AND DE-CONTAMINATION PROCEDURES. AN MDR #1226181-2012-00023 WILL BE FILED VERSUS THE INSTRUMENT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED TROPONIN I RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED AND A HIGHER RESULT WAS OBTAINED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED TROPONIN I RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM TROPONIN I FLEX® REAGENT CARTRIDGE MMI SIEMENS HEALTHCARE DIAGNOSTICS INC EA0308

    Patients

    Seq Age Sex Outcome Treatment
    1