BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM

    MDR report key: 3000418 · Received March 12, 2013

    Report

    Report Number
    1226181-2013-00118
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 12, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). DURING TROUBLESHOOTING, THE TSC SPECIALIST RECOMMENDED THAT THE CUSTOMER CHANGE THE SAMPLE PROBE AND RUN PRECISION, WHICH THE CUSTOMER DID. THE TSC SPECIALIST CONTACTED THE CUSTOMER TO FOLLOW-UP, AND THE INSTRUMENT HAD NOT PRODUCED ADDITIONAL DISCORDANT RESULTS SINCE THE SAMPLE PROBE WAS REPLACED. THE CAUSE OF THE DISCORDANT BUN, CREA, AND MG RESULTS WAS A MALFUNCTION OF THE SAMPLE PROBE. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW UREA NITROGEN (BUN) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE; A DISCORDANT, FALSELY LOW CREATININE (CREA) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE; AND A DISCORDANT, FALSELY ELEVATED MAGNESIUM (MG) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION RXL MAX WITH HM INSTRUMENT. IT IS UNKNOWN IF THE DISCORDANT BUN RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN, AND THE RERUN RESULT MATCHED THE PATIENT'S RESULT HISTORY, AND WAS REPORTED TO THE PHYSICIAN(S). THE DISCORDANT CREA RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS RERUN, AND THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THE DISCORDANT MAGNESIUM RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN IN DUPLICATE, AND THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT BUN, CREA, AND MG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103566 DIMENSION RXL MAX WITH HM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION RXL MAX WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1