BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

    MDR report key: 4200495 · Received October 24, 2014

    Report

    Report Number
    1226181-2014-00544
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 29, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 1226181-2014-00544 WAS FILED ON OCTOBER 24, 2014. ADDITIONAL INFORMATION (10/28/2014): DURING FOLLOW-UP WITH THE CUSTOMER, THE CUSTOMER STATED THAT THE ISSUE WAS RESOLVED. THE CUSTOMER DISCOVERED THAT THE INCORRECT QUALITY CONTROL (QC) WAS ON THE INSTRUMENT RUNNING AS LEVEL 1 CTNI QC. THE CAUSE OF THE LEVEL 1 CTNI QC BEING OUT OF RANGE WAS A USER ERROR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). DURING TROUBLESHOOTING, THE CCC SPECIALIST ADVISED THE CUSTOMER TO RUN THE LEVEL 1 CTNI QC IN A SAMPLE CUP FROM THE OTHER SYSTEM. THE CUSTOMER STATED THAT THEY COULD NOT TAKE THE SYSTEM DOWN TO PERFORM ANY MAINTENANCE BECAUSE THEY NEEDED TO RUN SAMPLES.

    Description of Event or Problem · 1

    LEVEL 1 QUALITY CONTROLS (QC) FOR CARDIAC TROPONIN I (CTNI) WERE OUT OF RANGE ON A DIMENSION VISTA 1500 INSTRUMENT. NO PATIENT SAMPLES WERE RUN WHILE QC WAS OUT OF RANGE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE CTNI QC BEING OUT OF RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679040 DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1