BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL 200

    MDR report key: 3781014 · Received April 30, 2014

    Report

    Report Number
    1226181-2014-00239
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 6, 2014
    Report Date
    April 8, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K073604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). DURING EVALUATION OF THE INSTRUMENT DATA, THE CCC SPECIALIST DISCOVERED THAT THE HIGH BIAS ON PATIENT RESULTS HAD BEGUN AFTER A NEW REAGENT FLEX WAS LOADED ONTO THE INSTRUMENT. THE REAGENT FLEX DID NOT HYDRATE PROPERLY AND THE CALIBRATION WAS PERFORMED ON THE INCORRECTLY HYDRATED REAGENT FLEX. THE CUSTOMER REPLACED THE REAGENT FLEX WITH A NEW ONE AND THE CALIBRATION WAS ACCEPTABLE. DURING FOLLOW-UP WITH THE CUSTOMER, THE CUSTOMER HAD NOT HAD ANY FURTHER ISSUES. THE CAUSE OF THE DISCORDANT BUN RESULTS WAS RELATED TO AN IMPROPERLY HYDRATED REAGENT FLEX. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED UREA NITROGEN (BUN) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON A DIMENSION EXL 200 INSTRUMENT. SOME DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND REQUIRED CORRECTED REPORTS UPON REPEAT TESTING. OTHER DISCORDANT RESULTS WERE NOT REPORTED TO PHYSICIAN(S) BECAUSE THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT PRIOR TO REPORTING RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT BUN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260468 DIMENSION EXL 200 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL 200

    Patients

    Seq Age Sex Outcome Treatment
    1