BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 3680755 · Received March 15, 2014

    Report

    Report Number
    1226181-2014-00138
    Event Type
    Malfunction
    Date Received
    March 15, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 17, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATING THE INSTRUMENT AND INSTRUMENT DATA, THE CSE REPLACED THE SAMPLE DRAIN, T-JUNCTION TUBING AND CHECKED INSTRUMENT ALIGNMENTS. THE CSE DETERMINED THAT THE CUSTOMER WAS SPINNING THE SAMPLES FOR 15 MINUTES, THAT EXCEEDS THE TUBE VENDOR SPECIFICATION OF 10 MINUTES. THE CSE INSTRUCTED THE CUSTOMER TO FOLLOW THE TUBE VENDOR SPECIFICATION FOR PROPER SAMPLE SPINNING TIME. THE CAUSE OF THE DISCORDANT SODIUM, POTASSIUM AND CHLORIDE RESULTS WAS UNKNOWN. THE CSE SUCCESSFULLY RAN A DILUENT CHECK AND 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 TWO PATIENTS. THE INITIAL NA, K AND CL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED ON THE SAME 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
    155809 DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1