BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL W/ LM

    MDR report key: 3212066 · Received July 8, 2013

    Report

    Report Number
    1226181-2013-00304
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K073604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). AFTER EVALUATION OF THE INSTRUMENT DATA, THE TSC SPECIALIST INSTRUCTED THE CUSTOMER TO CHANGE THE LAMP. DURING TROUBLESHOOTING, IT WAS DISCOVERED THAT THE TAPE WAS LOADED INCORRECTLY AND CUVETTES WERE TWISTED. ONCE RELOADED THE CUVETTES APPEARED BETTER. QUALITY CONTROLS WERE THEN RUN BY THE CUSTOMER AND WERE IN RANGE. THE CAUSE OF THE DISCORDANT, FALSELY LOW CALCIUM RESULT IS DUE TO THE INCORRECTLY LOADED TAPE USED FOR THE CUVETTES. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW CALCIUM RESULT WAS OBTAINED FOR ONE PATIENT SAMPLE ON A DIMENSION EXL W/ LM INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS THEN RERUN ON THE SAME INSTRUMENT AND RESULTED HIGHER. THE RERUN RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW CALCIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309059 DIMENSION EXL W/ LM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL W/ LM

    Patients

    Seq Age Sex Outcome Treatment
    1