BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1221805 · Received November 3, 2008

    Report

    Report Number
    2517506-2008-00100
    Event Type
    Other
    Date Received
    November 3, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 17, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    DHA
    PMA / PMN Number
    K970387
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE OF THE FALSELY DEPRESSED HCG WAS USER ERROR. THE SAMPLE WAS RUN WITH NO LEVEL SENSE AND MAY NOT HAVE PICKED UP ANY SAMPLE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED HCG RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED AND A POSITIVE 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 HCG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION CLINICAL CHEMISTRY SYSTEM HCG FLEX REAGENT CARTRIDGE DHA SIEMENS HEALTHCARE DIAGNOSTICS, INC. NA EC9205

    Patients

    Seq Age Sex Outcome Treatment
    1