BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA®

    MDR report key: 7823790 · Received August 28, 2018

    Report

    Report Number
    2517506-2018-00486
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Date of Event
    August 6, 2018
    Report Date
    September 27, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ORIGINAL MDR 2517506-2018-00486 WAS FILED 28-AUG-2018. ADDITIONAL INFORMATION (24-SEP-2018): SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) HAS REVIEWED THE INFORMATION PROVIDED. THE CAUSE OF THE DISCORDANCE BETWEEN THE CARDIAC TROPONIN I (CTNI) METHOD AND THE HIGH SENSITIVITY TROPONIN I (TNIH) METHOD IS UNKNOWN. THE INSTRUMENT DATA LOGS INDICATED THAT THERE WAS SOME DEGREE OF HEMOLYSIS WITH BOTH SAMPLE IDS (B)(4). QUALITY CONTROL, CALIBRATION, AND OTHER PATIENT SAMPLE RESULTS WERE RECOVERING ACCORDING TO EXPECTATIONS. NO PRODUCT NON-CONFORMANCE IS IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER CONCERNING HIGHER RESULTS OBTAINED FROM THE HIGH SENSITIVITY TROPONIN I FLEX REAGENT CARTRIDGE (TNIH) THAN THE RESULTS OBTAINED FROM THE SIEMENS TROPONIN I FLEX REAGENT CARTRIDGE (CTNI) ON THE DIMENSION VISTA SYSTEM. THE CUSTOMER WAS NOT REPORTING TNIH RESULTS AT THE TIME OF THIS EVENT. THE CUSTOMER WAS REPORTING THE CTNI RESULTS WHICH WERE PROCESSED CONCURRENTLY IN A COMPARISON STUDY. THERE WAS NO IMPACT TO THE PATIENT. THE PATIENT WAS DISCHARGED. THIS EVENT IS BEING FILED FOR THE TNIH FLEX REAGENT CARTRIDGE ALTHOUGH IT IS NOT A PRODUCT DISTRIBUTED IN THE U.S. THIS MDR WAS FILED CONSERVATIVELY DUE TO A SIMILAR PRODUCT (CTNI) WHICH IS REGISTERED AND MARKETED IN THE U.S. (PRODUCT NUMBER K6421, SIEMENS MATERIAL NUMBER (B)(4), 510K NUMBER K063756, GTIN (B)(4)). SIEMENS IS INVESTIGATING THE EVENT.

    Description of Event or Problem · 1

    DISCORDANT ELEVATED HIGH SENSITIVITY TROPONIN I (TNIH) RESULTS WERE OBTAINED ON A PATIENT'S SAMPLES ON THE DIMENSION VISTA 1500 SYSTEM. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLES WERE PROCESSED WITH A SIMILAR SIEMENS TROPONIN I METHODOLOGY (CTNI) AND LOWER RESULTS WERE OBTAINED AND REPORTED. THE SAME SAMPLES WERE PROCESSED FOR TROPONIN T ON AN ALTERNATE NON-SIEMENS METHODOLOGY AND LOW RESULTS WERE OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED TNIH RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662965 DIMENSION VISTA® DIMENSION VISTA® TNIH HIGH SENSITIVITY CARDIAC TROPONIN I FLEX® REAGENT CARTRIDG MMI SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR