BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2810226 · Received October 31, 2012

    Report

    Report Number
    1226181-2012-00107
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 2, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JGS
    PMA / PMN Number
    K944093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED SODIUM RESULTS WAS A MALFUNCTION OF THE IMT MODULE. THE SIEMENS HEALTHCARE DIAGNOSTICS TECHNICAL SERVICE CENTER REPRESENTATIVE DIRECTED THE CUSTOMER TO TROUBLESHOOTING ACTIVITIES. THE CUSTOMER DISCOVERED THAT THE THUMBSCREW ON THE BRACKET THAT HOLDS THE IMT MONOPUMP MOTOR ONTO THE PUMP HOUSING WAS LOOSE. TIGHTENING OF THE THUMBSCREW RESOLVED THE PROBLEM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED

    Description of Event or Problem · 1

    FALSELY DEPRESSED SODIUM RESULTS WERE OBTAINED ON A GROUP OF PATIENT SAMPLES. THE PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN. AFTER A SUBSEQUENT QUALITY CONTROL FAILURE AND A REVIEW OF PRIOR REPORTED RESULTS, THE SAMPLES WERE RE-RUN ON AN ALTERNATE INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. CORRECTED RESULTS WERE REPORTED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED SODIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM JGS SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW RXL MAX HM

    Patients

    Seq Age Sex Outcome Treatment
    1