BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2011004 · Received March 8, 2011

    Report

    Report Number
    1226181-2011-00020
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 27, 2011
    Report Date
    February 28, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD
    Product Code
    MMI
    PMA / PMN Number
    K944093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS FILED THE ORIGINAL MDR (B)(4) 2011. NEW INFORMATION: A SIEMENS HEALTHCARE DIAGNOSTICS INC FIELD SERVICE ENGINEER (FSE) ON THE CUSTOMER (B)(4) 2011 SITE EVALUATED THE INSTRUMENT AND REPORTED NEW ROOT CAUSE INFORMATION SUBSEQUENT TO THE INITIAL MDR FILING: 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 PREFORMED APPROPRIATE REPAIRS AND MAINTENANCE PROCEDURES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT WAS R1 PROBE MISALIGNMENT. A SIEMENS HEALTHCARE DIAGNOSTICS INC. TECHNICAL SERVICE CENTER REPRESENTATIVE DIRECTED THE CUSTOMER TO RESEAT AND RE-ALIGN THE R1 PROBE. 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 NEGATIVE RESULT WAS OBTAINED AND REPORTED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. 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 CLINICAL CHEMISTRY SYSTEM MMI SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD RXL MAX HM

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR