BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2625887 · Received June 22, 2012

    Report

    Report Number
    1226181-2012-00030
    Event Type
    Malfunction
    Date Received
    June 22, 2012
    Date of Event
    May 21, 2012
    Report Date
    May 22, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    CGZ
    PMA / PMN Number
    K944093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 CHLORIDE RESULTS IS MALFUNCTION OF THE IMT PUMP. THE SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE ACCOUNT AND REPLACED THE IMT PUMP. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSELY ELEVATED CHLORIDE (CL) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED AND LOWER RESULTS WERE OBTAINED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED CHLORIDE RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1