BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500

    MDR report key: 1820778 · Received August 27, 2010

    Report

    Report Number
    2247117-2010-00028
    Event Type
    Other
    Date Received
    August 27, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 5, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJQ
    PMA / PMN Number
    K905215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE TECHNICAL SERVICE ENGINEER (TSE) ANALYZED THE INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT DATA INDICATES THAT THE CAUSE OF 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) SAMPLES FROM DIFFERENT PTS ON DIFFERENT DAYS. THE INITIAL RESULTS FOR EACH PT WERE POSITIVE. PER THE LABORATORY'S PROTOCOL, SAMPLES WITH POSITIVE RESULTS WERE RE-TESTED. THE SAMPLE FOR THE 1ST PT WAS ALSO RUN DILUTED (1:10) WITH A FRESH REAGENT KIT (SAME LOT), AND AGAIN (NEAT) AFTER DECONTAMINATION OF THE SYSTEM, AND WITH ANTIBODIES BLOCKED. THE 1ST PT'S SAMPLE WAS RUN ON ADVIA CENTAUR XP AND ROCHE ELECSYS-THE RESULTS WERE NEGATIVE (<0.1 NG/ML). PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS HEALTHCARE TECHNICAL SERVICE ENGINEER (TSE) ANALYZED THE INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT DATA INDICATES THAT THE CAUSE OF 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 · 2

    DISCORDANT HIGH IMMULITE 2500 TROPONIN RESULTS WERE OBTAINED WITH TWO (2) SAMPLES FROM DIFFERENT PTS ON DIFFERENT DAYS. THE INITIAL RESULTS FOR EACH PT WERE POSITIVE. PER THE LABORATORY'S PROTOCOL, SAMPLES WITH POSITIVE RESULTS WERE RE-TESTED. THE 2ND PT'S SAMPLE WAS RUN ON ROCHE ELECSYS-THE RESULT WAS POSITIVE (8 NG/ML). PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. 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 IMMUNO-ASSAY JJQ SIEMENS HEALTHCARE DIAGNOSTICS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1
    2