BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 1000

    MDR report key: 1958924 · Received January 6, 2011

    Report

    Report Number
    2247117-2010-00055
    Event Type
    Other
    Date Received
    January 6, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 10, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CEW
    PMA / PMN Number
    K022603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVALUATION. THE FSE EXAMINED THE IMMULITE 1000 SYSTEM, PERFORMED DIAGNOSTIC CHECKS FOR PRECISION. CHECKED ALL FITTINGS FOR LEAKS, AND CHECKED ALL TUBING FOR DAMAGE - NO PROBLEMS WERE FOUND. THE FSE ALSO PRO-ACTIVELY REPLACED THE LEVEL SENSE PCB, UPDATED THE SOFTWARE, AND REPLACED THE KEYBOARD. 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.

    Description of Event or Problem · 1

    DISCORDANT HIGH IPTH (RPT) RESULTS WERE OBTAINED WITH THE TWO (2) FIRST AND THE TWO (2) SECOND POST-RESECTION IPTH SAMPLES FOR ONE (1) PT ON IMMULITE 1000. THE FIRST PARATHYROID EXCISION WAS PERFORMED AFTER BASELINE AND PRE-EXCISION IPTH LEVELS WERE ESTABLISHED. FIVE AND TEN MINUTE SAMPLES WERE TESTED AFTER THE FIRST EXCISION. THE PHYSICIAN PERFORMED A SECOND EXCISION BASED ON THE RESULTS OF THE FIRST POST-EXCISION IPTH SAMPLES. FIVE AND TEN MINUTE POST-EXCISION SAMPLES WERE ALSO TESTED FOLLOWING THE SECOND EXCISION, AND THESE ALSO YIELDED HIGH RESULTS. THE PHYSICIAN QUESTIONED THE HIGH RESULTS OF THE SECOND POST-EXCISION SAMPLES, WHICH WERE THEN RETESTED ON 2 OTHER SYSTEMS AND YIELDED LOW RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 1000 IMMUNO-ASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 208

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other