BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3965068 · Received July 29, 2014

    Report

    Report Number
    1226181-2014-00403
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 4, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCORDANT SODIUM RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS, INC. IS INVESTIGATING THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 1226181-2014-00403 WAS FILED ON JULY 29, 2014. ADDITIONAL INFORMATION (07/29/2014): A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST EVALUATED THE INSTRUMENT DATA, WHICH INDICATED THAT EITHER THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) PROBE OR AN ALIQUOT WELL HAD AN OCCLUSION. THE ISSUE WAS RESOLVED WITHOUT SERVICE, AS SAMPLES TESTED AFTER THE THREE DISCORDANT RESULTS WERE OBTAINED WERE PROCESSING AND RESULTING AS EXPECTED. PROPER SAMPLE HANDLING PRACTICES WERE DISCUSSED WITH THE CUSTOMER. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. ADDITIONAL INFORMATION (07/30/2014): THE CUSTOMER PROVIDED THE CORRECTED RESULTS AND STATED THAT THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). CORRECTION: SECTION B5 OF THE INITIAL MDR STATES THAT THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE DISCORDANT RESULT FOR ONE PATIENT SAMPLE WAS REPORTED TO THE PHYSICIAN(S). THE DISCORDANT RESULTS FOR THE TWO OTHER PATIENT SAMPLES WERE NOT REPORTED TO THE PHYSICIAN(S).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND STATED THAT DISCORDANT RESULTS HAD BEEN OBTAINED ON THREE PATIENT SAMPLES TESTED FOR SODIUM ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SODIUM RESULTS.

    Description of Event or Problem · 1

    THE DISCORDANT RESULT FOR PATIENT SAMPLE 671529 WAS REPORTED TO THE PHYSICIAN(S). A CORRECTED RESULT WAS SENT PRIOR TO THE PHYSICIAN(S) REVIEWING THE DISCORDANT RESULT. THE DISCORDANT RESULTS FOR PATIENT SAMPLES 671076 AND 672311 WERE NOT REPORTED TO THE PHYSICIAN(S). THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440868 DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1