BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2500

    MDR report key: 2390893 · Received December 28, 2011

    Report

    Report Number
    2247117-2011-00083
    Event Type
    Malfunction
    Date Received
    December 28, 2011
    Date of Event
    November 30, 2011
    Report Date
    December 7, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K033234
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC) ABOUT THIS EVENT. THE CUSTOMER CHECKED THE ADJUSTMENT AND QUALITY CONTROL DATA, AND THEY WERE WITHIN RANGE. THE CAUSE OF THE DISCORDANT IPT RESULT IS UNKNOWN, AND NO CONCLUSIONS CAN BE DRAWN AS TO WHAT CAUSED THE DISCORDANT IPT RESULT. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE SYSTEM IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT LOW INTACT PARATHYROID HORMONE (IPT) RESULT WAS OBTAINED WITH ONE (1) PATIENT SAMPLE ON AN IMMULITE 2500 ANALYZER. THE RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT DUE TO THE PATIENT'S HISTORY. THE SAMPLE WAS RETESTED ON ANOTHER ANALYZER. THE PHYSICIAN CONSIDERED THE IMMULITE 2500 IPT RESULT TO BE DISCORDANT WITH THE RESULT FROM THE OTHER ANALYZER, AS THE REPEAT TESTING FIT BETTER WITH THE PATIENT'S CLINICAL PICTURE. PATIENT CARE WAS NOT ALTERED OR PRESCRIBED DUE TO THE DISCORDANT IPT RESULT. THERE WAS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IPT RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR