BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 2173402 · Received July 23, 2011

    Report

    Report Number
    2247117-2011-00045
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 4, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    LGD
    PMA / PMN Number
    K970227
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    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 IMMULITE 2000 INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT DATA INDICATES THAT THE CAUSE OF THE DISCORDANT TROPONIN I RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT IMMULITE 2000 TROPONIN I RESULT WAS OBTAINED ON A PATIENT SAMPLE.THE RESULT WAS REPORTED TO THE PHYSICIAN. UPON RETEST ON AN ALTERNATE SYSTEM THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT. THERE IS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN I RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 IMMUNOASSAY ANALYZER, PRODUCT CODE: LGD SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization