BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500 STAT TROPONIN I

    MDR report key: 1062853 · Received June 18, 2008

    Report

    Report Number
    2017183-2008-00011
    Event Type
    Other
    Date Received
    June 18, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 26, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K034055
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 RESULT WAS DUE TO SAMPLE HANDLING. THE FSE RECOMMENDED THAT SAMPLE HANDLING PROCEDURES BE REVIEWED AT THE CUSTOMER SITE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A POSITIVE IMMULITE 2500 STAT TROPONIN RESULT WAS GENERATED ON A PATIENT SAMPLE. UPON REPEAT, THE TROPONIN RESULT WAS NEGATIVE. THE SAME SAMPLE WAS REPEATED AGAIN AND THE SAMPLE RESULT WAS POSITIVE. THE NEGATIVE RESULT WAS NOT REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN RESULTS.

    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 131

    Patients

    Seq Age Sex Outcome Treatment
    1