BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000

    MDR report key: 1889087 · Received October 28, 2010

    Report

    Report Number
    2247117-2010-00048
    Event Type
    Other
    Date Received
    October 28, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 5, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    DGC
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE TECHNICAL SERVICE ENGINEER (TSE) EVALUATED THE INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT PTH RESULTS IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    TWO (2) DISCORDANT LOW IMMULITE 2000 IPTH (PTH) RESULTS WERE OBTAINED ON DIFFERENT PT SAMPLES. THE LAB QUESTIONED THE RESULTS SINCE THEY WERE LOW AND THEY REPEATED BOTH SAMPLES. THE DISCORDANT LOW IPTH RESULTS WERE NOT REPORTED TO THE PHYSICIAN. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IPTH RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS HEALTHCARE TECHNICAL SERVICE ENGINEER (TSE) EVALUATED THE INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT PTH RESULTS IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    TWO (2) DISCORDANT LOW IMMULITE 2000 IPTH (PTH) RESULTS WERE OBTAINED ON DIFFERENT PT SAMPLES. THE LAB QUESTIONED THE RESULTS SINCE THEY WERE LOW AND THEY REPEATED BOTH SAMPLES. THE DISCORDANT LOW IPTH RESULTS WERE NOT REPORTED TO THE PHYSICIAN. 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 2000 IMMUNO-ASSAY DGC SIEMENS HEALTHCARE DIAGNOSTICS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1
    2