BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM

    MDR report key: 3051660 · Received April 10, 2013

    Report

    Report Number
    1226181-2013-00163
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL SERVICE CONSULTANT (TSC) WAS CONTACTED BY THE CUSTOMER. THE TSC REQUESTED THE INSTRUMENT DATA FILES AND QC DATA FROM THE CUSTOMER. THE CUSTOMER DID NOT PROVIDE ANY FILES TO ENABLE TROUBLESHOOTING THE ISSUE. THE CAUSE OF THE DISCORDANT SODIUM RESULT IS UNKNOWN. THE CUSTOMER DID NOT PROVIDE ADDITIONAL INFORMATION. THERE WERE NO OTHER KNOWN ISSUES AT THIS CUSTOMER SITE.

    Description of Event or Problem · 1

    A DISCORDANT LOW SODIUM (NA) RESULT WAS GENERATED BY THE DIMENSION RXL MAX WITH HM FOR ONE PATIENT SAMPLE. THE RESULT WAS REPORTED OUT OF THE LABORATORY. A NEW SAMPLE WAS DRAWN AND TESTED ON AN ALTERNATE SYSTEM. THE FIRST SAMPLE WAS REPEATED AND THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT SODIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152278 DIMENSION RXL MAX WITH HM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION RXL MAX WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1