BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 3408390 · Received October 14, 2013

    Report

    Report Number
    2247117-2013-00104
    Event Type
    Malfunction
    Date Received
    October 14, 2013
    Date of Event
    September 7, 2013
    Report Date
    September 18, 2013
    Manufacturer
    SIEMENS HEALTCHCARE DIAGNOSTICS INC
    Product Code
    JJQ
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE COMPLETED PREVENTIVE MAINTENANCE AND DID NOT FIND AN INSTRUMENT MALFUNCTION. THE CAUSE OF THE INCONSISTENT RUBELLA IGM RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    INCONSISTENT RUBELLA IGM RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN IMMULITE 2000 INSTRUMENT. NO RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AND RESULTED LOWER. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INCONSISTENT RUBELLA IGM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526323 IMMULITE 2000 IMMULITE 2000 JJQ SIEMENS HEALTCHCARE DIAGNOSTICS INC IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1