BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1843186 · Received September 23, 2010

    Report

    Report Number
    2517506-2010-00104
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 1, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC
    Product Code
    MMI
    PMA / PMN Number
    K010313
    Removal / Correction Number
    2517506-04/19/2010-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBABLE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT WAS SAMPLE INTEGRITY CUSTOMER SUSPECTED SAMPLE HANDLING ISSUE AND REPEATED THE SAMPLE. THE DIMENSION CTNI IFU STATES: "SPECIMENS SHOULD BE FREE OF PARTICULATE MATTER." 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 REPORTED TO THE PHYSICIAN. IT IS NOT KNOWN WHETHER THE PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED AND A NEGATIVE RESULT WAS OBTAINED. 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 DIMENSION® CTNI FLEX® REAGENT CARTRIDGE MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC BB1076

    Patients

    Seq Age Sex Outcome Treatment
    1