BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION

    MDR report key: 10421427 · Received August 18, 2020

    Report

    Report Number
    2517506-2020-00251
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    April 1, 2020
    Report Date
    August 18, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    MMI
    UDI-DI
    00842768037726
    PMA / PMN Number
    K190675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MDRS 2517506-2020-00250 AND 2517506-2020-252 WERE FILED FOR THE SAME EVENT. 2517506-2020-00151 AND 2517506-2020-00152 WERE PREVIOUSLY FILED FOR THE SAME EVENT ON 13-MAY-2020. SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THEIR INVESTIGATION OF THE DISCORDANT FALSELY ELEVATED CARDIAC TROPONIN I (TNIH) RESULT. HSC EVALUATED THE INFORMATION PROVIDED AND THE INSTRUMENT DATA FILES. NO PRODUCT NON-CONFORMANCE WAS IDENTIFIED WITH THE TNIH ASSAY OR INSTRUMENT. THE TNIH SAMPLE WAS RETURNED TO SIEMENS FOR EVALUATION BY ASSAY DEVELOPMENT. IT WAS DETERMINED THAT THE CUSTOMER IS NOT USING THE SIEMENS RECOMMENDED 99TH PERCENTILE FOR THE DIMENSION EXL TNIH METHOD OF 60.4 NG/ML BUT IS USING A VALUE OF 25 PG/ML. THIS CONTRIBUTED TO THE CUSTOMER'S PERCEPTION OF THE DIMENSION EXL METHOD BEING ELEVATED FOR THE PATIENT. THE CUSTOMER IS OPERATIONAL. THE CAUSE OF THE EVENT IS UNKNOWN. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (TNIH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DAY ON AN ALTERNATE NON-SIEMENS INSTRUMENT, A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED. DUE TO THE INITIAL ELEVATED TNIH RESULT, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY AND AN ELECTROCARDIOGRAM (ECG) AND ECHOGRAPHY WERE PERFORMED. THE PATIENT ALSO HAD A CHANGE IN PRESCRIPTION (PREDNISONE-CORTICOSTEROID). THERE WERE NO ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED TNIH RESULTS OR DUE TO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886509 DIMENSION DIMENSION® TNIH LOCI HIGH-SENSITIVITY TROPONIN I FLEX® REAGENT CARTRIDGE MMI SIEMENS HEALTHCARE DIAGNOSTICS INC 10471068 EE0227 00842768037726

    Patients

    Seq Age Sex Outcome Treatment
    1