BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2231777 · Received September 1, 2011

    Report

    Report Number
    2517506-2011-00134
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 13, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    DHA
    PMA / PMN Number
    K970387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 RESULT WAS USER ERROR. THE INSTRUMENT WAS RUN WITH A CONDITION WARNING DISPLAYED THAT A CUVETTE WASH SOLUTION WAS EMPTY. THE ASSAY RANGE SETTING WAS ALSO IMPROPERLY SET. IF PROPERLY SET BY THE CUSTOMER, IT WOULD HAVE FLAGGED THE ERRONEOUS RESULT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED (NEGATIVE) HCG RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED AND AN ELEVATED (POSITIVE) RESULT WAS OBTAINED. THE CORRECTED RESULT WAS REPORTED WITHIN ONE HOUR. IT IS UNKNOWN IF PATIENT TREATMENT WAS 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 HUMAN CHORIONIC GONADOTROPIN FLEX® REAGENT CARTRIDGE DHA SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW EB2155

    Patients

    Seq Age Sex Outcome Treatment
    1