BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA INTACT PTH CHEMILUMINESCENSE KIT

    MDR report key: 774387 · Received October 24, 2006

    Report

    Report Number
    2050095-2006-00006
    Event Type
    Injury
    Date Received
    October 24, 2006
    Date of Event
    March 3, 2005
    Report Date
    March 1, 2006
    Manufacturer
    NICHOLS INSTITUTE DIAGNOSTICS
    Product Code
    CEW
    PMA / PMN Number
    K954418
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS FOUND DURING A REVIEW OF NID FILES. NID HAS CEASED MANUFACTURING OPERATIONS AND NO LONGER MARKETS THIS PRODUCT. PRODUCT LABELING STATES THAT THE RESULTS OF THIS ASSAY "SHOULD BE INTERPRETED WITH CAUTION AND WITH CONSIDERATION OF THE OVERALL CLINICAL MANIFESTATION."

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THAT SHE UNDERWENT A PARATHYROIDECTOMY FOLLOWING ELEVATED PTH RESULTS OF LABORATORY TESTS CONDUCTED USING THIS ESSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA INTACT PTH CHEMILUMINESCENSE KIT INTACT PARATHYROID HORMONE (PTH) CEW NICHOLS INSTITUTE DIAGNOSTICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization