BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL

    MDR report key: 3114925 · Received May 15, 2013

    Report

    Report Number
    1226181-2013-00220
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 19, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K944093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL SERVICE CONSULTANT (TSC) WAS CONTACTED BY THE CUSTOMER. THE TSC ANALYZED THE INSTRUMENT DATA AND DETERMINED THAT THE CAUSE OF THE DISCORDANT SODIUM, POTASSIUM AND CHLORIDE RESULTS WERE DUE TO USER ERROR; IMPROPER SAMPLE TUBE SPINNING. THE TUBE VENDOR RECOMMENDS PULLING 100 - 1300 G FORCE FOR 10 MINUTES IN ORDER TO GET A CLEAN SAMPLE. SIEMENS INSTRUCTED THE CUSTOMER TO FOLLOW THE TUBE MANUFACTURER'S RECOMMENDATION FOR PROPER CENTRIFUGATION TIMES AND SPEED. ADDITIONALLY, THE TSC INSTRUCTED THE CUSTOMER TO ALLOW TUBES TO CLOT FOR 30 MINUTES, TO ENSURE COMPLETE CLOT FORMATION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS AND FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) RESULTS WERE OBTAINED ON A DIMENSION EXL INSTRUMENT FOR ONE PATIENT. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RETESTED TWICE ON (B)(6) 2013 AND A REDRAWN SAMPLE WAS TESTED ON THE SAME INSTRUMENT ON (B)(6) 2013. 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, POTASSIUM AND CHLORIDE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214856 DIMENSION EXL CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION EXL

    Patients

    Seq Age Sex Outcome Treatment
    1