BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM

    MDR report key: 2883707 · Received December 21, 2012

    Report

    Report Number
    1226181-2012-00167
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 1, 2012
    Report Date
    December 5, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JGS
    PMA / PMN Number
    K944093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT, THE FIELD SERVICE ENGINEER DETERMINED THAT THE CAUSE FOR THE LOW SODIUM RESULTS WAS THAT THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) PROBE WAS OUT OF ALIGNMENT. THE FSE REALIGNED THE IMT PROBE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT LOW SODIUM PATIENT RESULTS WERE GENERATED BY THE DIMENSION RXL MAX WITH HM SYSTEM. THE INITIAL RESULTS WERE BELOW THE LABORATORY'S NORMAL RANGE OF 132-148 MMOL/L. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WERE NO CHANGES TO THE PATIENTS CARE OR TREATMENT. THE SAMPLES WERE RETESTED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1