BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2871079 · Received December 12, 2012

    Report

    Report Number
    1226181-2012-00145
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 23, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC-BROOKFIELD
    Product Code
    CFR
    PMA / PMN Number
    K944093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED GLUCOSE RESULTS IS AN INSTRUMENT MALFUNCTION. THE SIEMENS HEALTHCARE DIAGNOSTICS TECHNICAL SERVICE CENTER REPRESENTATIVE DIRECTED THE CUSTOMER PERFORMED TROUBLESHOOTING OPERATIONS INCLUDING CLEANING AND REPLACEMENT OF SOME PHOTOMETER WINDOWS. THE ACCOUNT REPORTS NO PROBLEMS WITH GLUCOSE IMPRECISION AFTER COMPLETION OF REPAIRS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSELY ELEVATED GLUCOSE RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES. PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN. IMPRECISION WAS NOTED WITHIN THE LABORATORY AND REPEAT RUNS WERE PERFORMED AND HIGHER RESULTS OBTAINED. CORRECTED RESULTS WERE ISSUED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED GLUCOSE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM DIMENSION® EXL® CLINICAL CHEMISTRY SYSTEM CFR SIEMENS HEALTHCARE DIAGNOSTICS INC-BROOKFIELD EXL

    Patients

    Seq Age Sex Outcome Treatment
    1