BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA INTACT PTH CHEMILUMINESCENCSE KIT

    MDR report key: 774377 · Received October 24, 2006

    Report

    Report Number
    2050095-2006-00003
    Event Type
    Injury
    Date Received
    October 24, 2006
    Date of Event
    February 1, 2001
    Report Date
    February 1, 2001
    Manufacturer
    NICHOLS INSTITUTE DIAGNOSTICS
    Product Code
    CEW
    PMA / PMN Number
    K954418
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED ON INFORMATION FOUND DURING A REVIEW OF NID FILES. NID HAS CEASED MANUFACTURING OPERATIONS AND NO LONGER MARKETS THIS PRODUCT.

    Description of Event or Problem · 1

    SPECTRA LABORATORY REPORTED THAT THE NA INTACT PTH ASSAY PROVIDED HIGH RESULTS (APPROX. 1600 PG/ML) ON TWO PATIENTS TESTED IN ITS SITE. WHEN RETESTED USING ANOTHER ASSAY (IRMA PTH), BOTH PATIENTS VALUES WERE BELOW 2 PG/ML. THE LABORATORY ALSO REPORTED THAT ANOTHER PATIENT TREATED AT ANOTHER SITE MAY HAVE UNDERGONE UNNECESSARY SURGERY BECAUSE OF A SIMILAR DESCREPANCY. THIS INFORMATION WAS FOUND DURING REVIEW OF NID FILES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization