BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1812611 · Received August 24, 2010

    Report

    Report Number
    2517506-2010-00098
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 6, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    DHA
    PMA / PMN Number
    K970387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 HCG IS USER ERROR. THE SAMPLE WAS MOVED AFTER LEVEL SENSE WAS PERFORMED BUT BEFORE THE SAMPLE WAS ASPIRATED.

    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 DA0349

    Patients

    Seq Age Sex Outcome Treatment
    1