BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2830375 · Received November 13, 2012

    Report

    Report Number
    2517506-2012-00336
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 14, 2012
    Report Date
    October 14, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    MMI
    PMA / PMN Number
    K010313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 SAMPLE INTEGRITY. THE ACCOUNT DOES NOT MEET THE TUBE MANUFACTURER'S RECOMMENDATIONS FOR SPIN SPEED AND DURATION. THE IFU FOR DIMENSION CTNI FLEX REAGENT CARTRIDGE CONTAINS THE FOLLOWING INFORMATION: "FOLLOW THE INSTRUCTIONS WITH YOUR SPECIMEN COLLECTION DEVICE FOR USE AND PROCESSING." AND "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. THE SAMPLE WAS RERUN AND A LOWER RESULT WAS OBTAINED. A CORRECTED REPORTED WAS ISSUED. IT IS UNKNOWN IF PATIENT TREATMENT WAS 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 CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE MMI SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DA3213

    Patients

    Seq Age Sex Outcome Treatment
    1