BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 4259255 · Received November 18, 2014

    Report

    Report Number
    1226181-2014-00589
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    October 24, 2014
    Report Date
    October 24, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    MZV
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER STATED TO CCC THAT CONTROLS WERE WITHIN RANGE AND NO ERRORS OCCURRED AT THE TIME OF EVENT. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED K RESULT IS UNKNOWN, AS THE SAMPLE RESULTED AS EXPECTED UPON REPEAT TESTING 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

    A DISCORDANT, FALSELY ELEVATED POTASSIUM (K) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). 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 K RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744925 DIMENSION EXL WITH LM CLINICAL CHEMISTRY ANALYZER MZV SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1