BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 5017988 · Received August 20, 2015

    Report

    Report Number
    1226181-2015-00469
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    July 23, 2015
    Report Date
    August 4, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEADQUARTER SUPPORT CENTER (HSC) SPECIALIST EVALUATED THE INSTRUMENT DATA. THE SAMPLE WAS CENTRIFUGED AT THE CUSTOMER'S OFF SITE COLLECTION CENTER. HSC RECOMMENDS REVIEW OF PROPER PRE ANALYTICAL SAMPLE HANDLING PROCEDURES. THE CAUSE OF THE DISCORDANT, FALSELY LOW NA, K AND CL RESULTS IS UNKNOWN AS THE SAMPLE RESULTED AS EXPECTED WHEN REPEATED ON THE SAME INSTRUMENT. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT, RESULTING HIGHER. 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, FALSELY LOW NA, K AND CL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551648 DIMENSION EXL WITH LM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1