BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2616918 · Received June 14, 2012

    Report

    Report Number
    2517506-2012-00101
    Event Type
    Malfunction
    Date Received
    June 14, 2012
    Date of Event
    December 1, 2011
    Report Date
    December 1, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    CGZ
    PMA / PMN Number
    K970330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 CHLORIDE RESULT IS SAMPLE INTEGRITY. THE IFU FOR DIMENSION QUIKLYTE IMT SENSOR CONTAINS THE FOLLOWING INFORMATION: "FOLLOW THE INSTRUCTIONS WITH YOUR SPECIMEN COLLECTION DEVICE FOR COLLECTION, TUBE HANDLING, SPIN TIMES, AND G-FORCE ESPECIALLY WHEN USING PLASTIC BLOOD COLLECTION TUBES. FAILURE TO FOLLOW THE BLOOD COLLECTION TUBE INSTRUCTIONS MAY RESULT IN INCREASED MAINTENANCE OR TROUBLESHOOTING OF THE IMT SYSTEM." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED CHLORIDE (CL) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED AND A HIGHER RESULT WAS OBTAINED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED CHLORIDE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM QUIKLYTE® INTEGRATED MULTISENSOR CGZ SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW

    Patients

    Seq Age Sex Outcome Treatment
    1