BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 3022587 · Received March 27, 2013

    Report

    Report Number
    2247117-2013-00030
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 1, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJQ
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO REVIEW INSTRUMENT DATA. THE CUSTOMER TOLD THE FSE THAT HIS ASSISTANCE WAS NOT REQUIRED, AS THEY BELIEVE THE ISSUE WAS LIMITED TO THIS ONE SAMPLE. THE CUSTOMER DID CONFIRM TO THE FSE THAT THEY HAVE RUN THIS SAMPLE PREVIOUSLY WITHOUT ISSUES. THE CAUSE OF THE EVENT IS UNKNOWN. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT DILUTION RESULTS FOR CA 15-3 WERE OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 INSTRUMENT. THE CUSTOMER RAN THE NEAT SAMPLE TWO TIMES AND PERFORMED A 1:3, 1:5, AND A 1:10 DILUTION ON THE NEAT SAMPLE. THE RESULTS ON THE DILUTED SAMPLES DID NOT MATCH THE NEAT RESULT. IT IS UNKNOWN IF PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DILUTION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126094 IMMULITE 2000 IMMULITE 2000 JJQ SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1