BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALCITONIN CHEMILUMINESCENCE KIT

    MDR report key: 774398 · Received October 24, 2006

    Report

    Report Number
    2050095-2006-00005
    Event Type
    Injury
    Date Received
    October 24, 2006
    Date of Event
    October 1, 2001
    Report Date
    October 1, 2003
    Manufacturer
    NICHOLS INSTITUTE DIAGNOSTICS
    Product Code
    JKR
    PMA / PMN Number
    K945961
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THE PRODUCT LABELING STATES: "FOR DIAGNOSTIC PURPOSES, VALUES OBTAINED WITH THE NICHOLS ADVANTAGE CALCITONIN SHOULD BE USED AS AN ADJUNCT TO OTHER DATA AVAILABLE TO THE PHYSICIAN."

    Description of Event or Problem · 1

    A PATIENT IN ANOTHER COUNTRY CLAIMED THAT SHE UNDERWENT UNNECESSARY SURGERY FOLLOWING A FALSE POSITIVE RESULT OBTAINED BY LABORATORY TESTS UTILIZING THIS ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALCITONIN CHEMILUMINESCENCE KIT CALCITONIN IMMUNOASSAY JKR NICHOLS INSTITUTE DIAGNOSTICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization