BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500

    MDR report key: 1933426 · Received December 15, 2010

    Report

    Report Number
    2247117-2010-00057
    Event Type
    Other
    Date Received
    December 15, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJQ
    PMA / PMN Number
    K905215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT INDICATE THAT THE CAUSE FOR THE DISCORDANT TROPONIN RESULT 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 LAB REPEATED THE SAMPLES ON A SECOND SYSTEM, WHICH GAVE SIMILAR RESULTS. THE SAMPLES WERE THEN TREATED WITH HBT TUBES AND THE RESULTS FOR BOTH PT'S WERE NEGATIVE. THERE WAS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT INDICATE THAT THE CAUSE FOR THE DISCORDANT TROPONIN RESULT IS 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 LAB REPEATED THE SAMPLES ON A SECOND SYSTEM, WHICH GAVE SIMILAR RESULTS. THE SAMPLES WERE THEN TREATED WITH HBT TUBES AND THE RESULTS FOR BOTH PT'S WERE NEGATIVE. THERE WAS NO KNOWN 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 IMMUNO-ASSAY JJQ SIEMENS HEALTHCARE DIAGNOSTICS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1
    2