BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000 INTACT PTH

    MDR report key: 1240875 · Received November 6, 2008

    Report

    Report Number
    2017183-2008-00046
    Event Type
    Other
    Date Received
    November 6, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 18, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CEW
    PMA / PMN Number
    K013566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INCLUDE THAT THE CAUSE FOR THE DISCORDANT INTACT PTH WAS DUE TO THE USE OF AN OLD ADJUSTER. A NEW ADJUSTER HAS BEEN PUT INTO PLACE AND THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT (LOW) IMMULITE 2000 INTACT PTH ASSAY RESULTS WERE REPORTED ON MULTIPLE PATIENT SAMPLES. UPON REVIEW OF THE DATA BY THE CUSTOMER, IT WAS DETERMINED THAT THE QC RESULTS WERE OUT OF RANGE WHEN THESE PATIENT RESULTS WERE GENERATED. THE INITIAL RESULTS SHOULD NOT HAVE BEEN REPORTED DUE TO THE QC RESULTS BEING OUT OF RANGE. PATIENT TREATMENT WAS NOT ALTERED, AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT INTACT PTH ASSAY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 INTACT PTH INTACT PTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 174

    Patients

    Seq Age Sex Outcome Treatment
    1