BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 3873239 · Received June 13, 2014

    Report

    Report Number
    2247117-2014-00034
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 20, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJQ
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE ANALYZED THE INSTRUMENT AND INSTRUMENT DATA AND DETERMINED THAT THERE WAS CONTAMINATION OF THE INSTRUMENT FLUIDICS AND SUBSTRATE DURING THE TIME OF THE EVENT. THE CSE REPLACED THE SUBSTRATE BOTTLE, SUBSTRATE PUMP AND TUBING, SAMPLE PROBE AND CARBON DIOXIDE SCRUBBER. THE CAUSE OF THE DISCORDANT PGN AND HCG RESULTS IS UNKNOWN. THE CSE SUCCESSFULLY RAN QC. THE SYSTEM IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT PROGESTERONE (PGN) AND HUMAN CHORIONIC GONADOTROPIN (HCG) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN IMMULITE 2000 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. THE REPEATED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PGN AND HCG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349611 IMMULITE 2000 IMMUNOASSAY ANALYZER JJQ SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1