BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500 STAT TROPONIN I

    MDR report key: 1163265 · Received September 15, 2008

    Report

    Report Number
    2017183-2008-00033
    Event Type
    Other
    Date Received
    September 15, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 8, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K034055
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT TROPONIN RESULTS IS UNK. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. ADDITIONAL LOT NUMBER: 131

    Description of Event or Problem · 1

    MULTIPLE POSITIVE IMMULITE 2500 TROPONIN PATIENT RESULTS WERE OBTAINED. ONE PATIENT UNDERWENT AN ANGIOGRAM. THE CUSTOMER DID NOT PROVIDE ANY TEST RESULTS REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 STAT TROPONIN I TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other