BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500

    MDR report key: 1879975 · Received October 19, 2010

    Report

    Report Number
    2247117-2010-00041
    Event Type
    Other
    Date Received
    October 19, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 19, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJQ
    PMA / PMN Number
    K905215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SVC ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVAL. ANALYSIS OF THE INSTRUMENT AND THE INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT TROPONIN RESULTS IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT HIGH IMMULITE 2500 TROPONIN RESULTS WERE OBTAINED WITH TWO (2) PT SAMPLES. THE INITIAL RESULTS WERE POSITIVE. THE REPEAT RESULTS WERE NEGATIVE. THE DISCORDANT HIGH INITIAL RESULT FOR ID# (B)(6) WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER DID NOT PROVIDE ANY INFO TO INDICATE WHETHER OR NOT THE DISCORDANT HIGH RESULT FOR ID (B)(6) WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER DECLINED TO PROVIDE ANY INFO ABOUT THE PT CARE.

    Additional Manufacturer Narrative · 2

    A SIEMENS HEALTHCARE FIELD SVC ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVAL. ANALYSIS OF THE INSTRUMENT AND THE INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT TROPONIN RESULTS AS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    DISCORDANT HIGH IMMULITE 2500 TROPONIN RESULTS WERE OBTAINED WITH TWO (2) PT SAMPLES. THE INITIAL RESULTS WERE POSITIVE. THE REPEAT RESULTS WERE NEGATIVE. THE DISCORDANT HIGH INITIAL RESULT FOR ID# (B)(6) WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER DID NOT PROVIDE ANY INFO TO INDICATE WHETHER OR NOT THE DISCORDANT HIGH RESULT FOR ID (B)(6) WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER DECLINED TO PROVIDE ANY INFO ABOUT THE PT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 IMMUNO-ASSAY JJQ SIEMENS HEALTHCARE DIAGNOSTICS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1
    2