BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3020287 · Received March 25, 2013

    Report

    Report Number
    1226181-2013-00141
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL SOLUTIONS CENTER (TSC) SPECIALIST EVALUATED THE INSTRUMENT DATA DURING TROUBLESHOOTING WITH THE CUSTOMER. THE TSC SPECIALIST DID NOT DISCOVER AN INSTRUMENT MALFUNCTION, AND THE ISSUE HAD BEEN LIMITED TO THIS PATIENT SAMPLE. THE CAUSE OF THE DISCODANT, FALSELY LOW RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW CALCIUM RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN IN DUPLICATE ON AN ALTERNATE INSTRUMENT, AND THE CALCIUM RESULTS MATCHED THE PATIENT'S PREVIOUS RESULT. THE PATIENT'S CHEMISTRY PANEL WAS THEN RERUN, AND THE PATIENT'S SODIUM (NA), POTASSIUM (K), CHLORIDE (CL), UREA NITROGEN (BUN), CREATININE (CREA), GLUCOSE, PHOSPHOROUS (PO4), MAGNESIUM (MG), TOTAL PROTEIN (TP), AND ALBUMIN (ALB) RESULTS ALL RESULTED HIGHER. THE RERUN RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121455 DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM CHL SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1