BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3092343 · Received May 3, 2013

    Report

    Report Number
    1226181-2013-00200
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 3, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). AFTER EVALUATION OF THE INSTRUMENT DATA, THE TSC SPECIALIST DID NOT FIND AN INSTRUMENT MALFUNCTION. THE CAUSE OF THE DISCORDANT CREA, GLU, AST, ALTI, BUN, TP, ASL, CRP, AND FER ON ONE PATIENT SAMPLE IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT CREATININE (CREA), GLUCOSE (GLU), ASPARTATE AMINOTRANSFERASE (AST), ALANINE TRANSAMINASE (ALTI), UREA NITROGEN (BUN), TOTAL PROTEIN (TP), ANTISTREPTOLYSIN O (ASL), C-REACTIVE PROTEIN (CRP), AND FERRITIN (FER) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLE WAS THEN RERUN ON THE SAME INSTRUMENT AND AN ALTERNATE INSTRUMENT. THE SAMPLE WAS ALSO REPEATED IN DUPLICATE FOR FER ON THE INITIAL INSTRUMENT. THE RERUN RESULTS FROM THE ALTERNATE INSTRUMENT WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CREA, GLU, AST, ALTI, BUN, TP, ASL, CRP, AND FER RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194425 DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR