BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500

    MDR report key: 1820779 · Received August 27, 2010

    Report

    Report Number
    2247117-2010-00027
    Event Type
    Other
    Date Received
    August 27, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 10, 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) OF THE THREE (3) SAMPLES DRAWN FROM ONE (1) PT. THE RESULT OF THE FIRST SAMPLE WAS POSITIVE. PER THE LABORATORY'S PROTOCOL, A POSITIVE RESULT MUST BE CONFIRMED WITH A SECOND SAMPLE, WHICH WAS DRAWN AND TESTED NEGATIVE. A THIRD SAMPLE WAS DRAWN AND TESTED POSITIVE. ALL THREE SAMPLES WERE LATER RE-TESTED AND THE RESULTS WERE ALL NEGATIVE (I.E., <0.2 NG/ML). PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NOT REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT 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) OF THE THREE (3) SAMPLES DRAWN FROM ONE (1) PT. THE RESULT OF THE FIRST SAMPLE WAS POSITIVE. PER THE LABORATORY'S PROTOCOL, A POSITIVE RESULT MUST BE CONFIRMED WITH A SECOND SAMPLE, WHICH WAS DRAWN AND TESTED NEGATIVE. A THIRD SAMPLE WAS DRAWN AND TESTED POSITIVE. ALL THREE SAMPLES WERE LATER RE-TESTED AND THE RESULTS WERE ALL NEGATIVE (I.E., <0.2 NG/ML). PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NOT REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

    Additional Manufacturer Narrative · 3

    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 · 3

    DISCORDANT HIGH IMMULITE 2500 TROPONIN RESULTS WERE OBTAINED WITH TWO (2) OF THE THREE (3) SAMPLES DRAWN FROM ONE (1) PT. THE RESULT OF THE FIRST SAMPLE WAS POSITIVE. PER THE LABORATORY'S PROTOCOL, A POSITIVE RESULT MUST BE CONFIRMED WITH A SECOND SAMPLE, WHICH WAS DRAWN AND TESTED NEGATIVE. A THIRD SAMPLE WAS DRAWN AND TESTED POSITIVE. ALL THREE SAMPLES WERE LATER RE-TESTED AND THE RESULTS WERE ALL NEGATIVE (I.E., <0.2 NG/ML). PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NOT REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT 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
    3