BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 3654262 · Received March 3, 2014

    Report

    Report Number
    1226181-2014-00108
    Event Type
    Malfunction
    Date Received
    March 3, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 5, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL SERVICE CONSULTANT (TSC) WAS CONTACTED BY THE CUSTOMER. THE TSC EVALUATED THE INSTRUMENT DATA AND DID NOT FIND AN INSTRUMENT MALFUNCTION. THE TSC DETERMINED THAT THE CUSTOMER WAS SPINNING THE SODIUM, POTASSIUM AND CHLORIDE SAMPLES AT 4400 RPM, THAT EXCEEDS THE TUBE VENDOR SPECIFICATIONS. THE TSC INSTRUCTED THE CUSTOMER TO FOLLOW THE TUBE VENDOR SPECIFICATION FOR PROPER SAMPLE SPINNING, ENSURE SAMPLE TUBES ARE NOT PARTIALLY FILLED AND TO PROPERLY MAINTAIN AND REPLACE THE DILUENT CHECK SOLUTION ON THE SYSTEM. THE CAUSE OF THE DISCORDANT SODIUM, POTASSIUM AND CHLORIDE RESULTS IS UNKNOWN. THE CUSTOMER SUCCESSFULLY RAN QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. 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 WITH LM INSTRUMENT ON SIX PATIENTS. THE INITIAL NA, K AND CL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT AND THOSE NA, K AND CL RESULTS WERE SENT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NA, K AND CL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125693 DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1