BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL 200

    MDR report key: 3872882 · Received June 13, 2014

    Report

    Report Number
    1226181-2014-00324
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 19, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K073604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). AFTER EVALUATION OF THE INSTRUMENT DATA, THE CCC DISCOVERED THAT ON (B)(4) 2014 THE CUSTOMER ACCEPTED A CALIBRATION THAT WAS NOT WITHIN SPECIFICATIONS. CCC INSTRUCTED THE CUSTOMER TO CLEAN THE WINDOWS, REPLACE THE SAMPLE PROBES AND REAGENT PROBE 1 AND RE-CALIBRATE THE ASSAY. A REPEAT PRECISION STUDY WAS RUN, RESULTING WITHIN RANGE. UPON FOLLOW-UP, THE CUSTOMER STATED THAT THE ISSUE HAD BEEN RESOLVED AND THEY ARE REPORTING HB1C RESULTS. THE CAUSE OF THE CUSTOMER ACCEPTING A CALIBRATION THAT IS NOT WITHIN SPECIFICATIONS IS FAILURE TO FOLLOW INSTRUCTIONS. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED HB1C RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED HEMOGLOBIN A1C (HB1C) RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES ON A DIMENSION EXL 200 INSTRUMENT. THE CUSTOMER ONLY PROVIDED THE RESULTS OF ONE PATIENT SAMPLE. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED IT. THE PATIENT WAS REDRAWN AND THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT, RESULTING LOWER. IT IS UNKNOWN IF THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED HB1C RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350270 DIMENSION EXL 200 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL 200

    Patients

    Seq Age Sex Outcome Treatment
    1