BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 8916664 · Received August 21, 2019

    Report

    Report Number
    2517506-2019-00329
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    July 26, 2019
    Report Date
    September 12, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED INITIAL MDR 2517506-2019-00329 ON 21-AUG-2019. CORRECTED INFORMATION (12-SEP-2019): SECTION D2 OF THE INITIAL MDR HAD A TYPOGRAPHICAL ERROR INDICATING THE PRODUCT CODE "JHJ". THE CORRECT PRODUCT CODE IS JJE. SECTION D2 WAS UPDATED TO REFLECT THE CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT A DISCORDANT CARBON DIOXIDE (CO2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. A SIEMENS TECHNICAL APPLICATION SPECIALIST (TAS) WAS DISPATCHED TO THE CUSTOMER'S SITE, CLEAN THE ALIQUOT PROBE, AND RAN PRECISION STUDY. THE PRECISION STUDY RECOVERED ACCEPTABLY. SIEMENS FURTHER INVESTIGATED THE ISSUE AND DETERMINED THAT SAMPLE SPECIFIC ISSUE, SUCH AS SAMPLE HANDLING AND SAMPLE INTEGRITY, POTENTIALLY CONTRIBUTED TO THE DISCORDANT CO2 RESULT. THE PRESENCE OF CELLULAR DEBRIS, GEL GLOBULES, OR OTHER SAMPLE ARTIFACTS CAN IMPACT SAMPLING ACCURACY AND RESULTS. THE CUSTOMER CONTINUED TO RUN SAMPLES ON THE INSTRUMENT AND DID NOT REPORT ADDITIONAL DISCORDANT RESULTS. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW CARBON DIOXIDE (CO2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS AUTOMATICALLY REPEATED ON THE SAME INSTRUMENT AND RUN ON AN ALTERNATE DIMENSION VISTA 1500 INSTRUMENT. BOTH REPEAT RESULTS WERE HIGHER THAN THE DISCORDANT RESULT. THE REPEAT RESULT OBTAINED FROM THE ALTERNATE INSTRUMENT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW CO2 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712410 DIMENSION VISTA 1500 DIMENSION VISTA 1500 JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1