BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 1000

    MDR report key: 3033556 · Received April 3, 2013

    Report

    Report Number
    2247117-2013-00035
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 5, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K022603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE EVALUATED THE INSTRUMENT AND INSTRUMENT DATA. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DISCOVERED THAT THE 250 UL SYRINGE WAS LOOSE. THE FSE REPLACED THE SYRINGE AND PROACTIVELY REPLACED THE SAMPLE PROBE AND TIPS. QUALITY CONTROLS WERE RUN AND ALL WERE WITHIN RANGE. A PATIENT SAMPLE WAS RUN WITH DILUENT, AND RESULTED AS EXPECTED. THE CAUSE OF THE INCONSISTENT HCG RESULTS WAS A MALFUNCTION OF THE 250 UL SYRINGE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE OPERATOR OF AN IMMULITE 1000 INSTRUMENT OBTAINED INCONSISTENT HUMAN CHORIONIC GONADOTROPIN (HCG) RESULTS FOR ONE PATIENT SAMPLE. THE SAMPLE WAS RUN FOUR TIMES, AND THE DILUTION RESULTS WERE LOWER THAN THE CLINICAL PICTURE OF THE PATIENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE INITIAL RESULT. THE PATIENT WAS GIVEN AN ULTRASOUND, AND THE ULTRASOUND MATCHED THE CLINICAL PICTURE OF THE PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INCONSISTENT HCG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135943 IMMULITE 1000 IMMULITE 1000 DHA SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 1000

    Patients

    Seq Age Sex Outcome Treatment
    1