BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500

    MDR report key: 1874234 · Received October 12, 2010

    Report

    Report Number
    2247117-2010-00042
    Event Type
    Other
    Date Received
    October 12, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJQ
    PMA / PMN Number
    K905215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE 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 IPTH RESULTS IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT LOW I-PTH (RPT) RESULTS WERE OBTAINED WITH ONE (1) PT SAMPLE RUN ON IMMULITE 2500. ONE REPLICATE OF THE PT'S INTRA-OPERATIVE SAMPLE WAS TESTED INITIALLY. THE SAMPLE WAS THEN RE-TESTED IN TRIPLICATE, AND THE REPEAT RESULTS WERE LOWER. THE SAME SAMPLE WAS ALSO TESTED FOR I-PTH (IPT), AND THE RESULT OBTAINED AGREED WITH THE INITIAL I-PTH (RPT) RESULT. THE DISCORDANT LOW I-PTH REPEAT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE PT HAD SURGERY, AND WAS TESTED POST-OPERATIVELY FOR I-PTH (RPT) AND I-PTH (IPT). PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IPTH 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 65 YR