BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTACT PTH, IRMA, 100T

    MDR report key: 774280 · Received October 24, 2006

    Report

    Report Number
    2050095-2006-00001
    Event Type
    Injury
    Date Received
    October 24, 2006
    Date of Event
    April 22, 2004
    Report Date
    April 22, 2004
    Manufacturer
    NICHOLS INSTITUTE DIAGNOSTICS
    Product Code
    CEW
    PMA / PMN Number
    k861797
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED ON AN E-MAIL FROM A PHYSICIAN TO NID EMPLOYEES FOUND DURING A REVIEW OF NID CORRESPONDENCE FILES. THIS IS NOT A REPORT ABOUT A SPECIFIC PATIENT, BUT RATHER GENERAL INFORMATION FROM THE REPORTER ABOUT THE REPORTED EXPERIENCE OF ANOTHER PHYSICIAN. PRODUCT LABELING STATES THAT THE RESULT OF THIS ASSAY "SHOULD BE INTERPRETED WITH CAUTION AND WITH CONSIDERATION OF THE OVERALL CLINICAL MANIFESTATION." NID HAS CEASED MANUFACTURING OPERATIONS AND NO LONGER MARKETS THIS PRODUCT.

    Description of Event or Problem · 1

    A REVIEW OF CORRESPONDENCE FILES AT NID HAS SHOWN THAT NID RECEIVED AN EMAIL ON APRIL 22, 2004 FROM A PEDIATRIC ENDOCRINOLOGIST WHO WORKED WITH PEDIATRIC NEPHROLOGISTS AT THE SAME HOSPITAL. THE HOSPITAL PERFORMED THE NICHOLS INSTITUTE INTACT PTH (#40-2171) ASSAY IN ITS LAB. THE ENDOCRINOLOGIST REPORTED THAT THE NEPHROLOGISTS TOLD HIM THAT THEY "FREQUENTLY SEE EXTRAORDINARILY HIGH PTH VALUES WITH THE IPTH ASSAY ON RENAL FAILURE KIDS. THESE VALUES ARE 250 TO 500 TO 1000 TO 2000." THE REPORTER STATED THAT ONE OF THE NEPHROLOGISTS TOLD THE REPORTER THAT "HE HAS TAKEN OUT PARATHYROID GLANDS ONLY TO FIND THAT THERE WAS NO ADENOMA." THE REPORTER SUSPECTED THAT THE ASSAY WAS "NOT MEASURING TRULY INTACT PTH." THE REPORTER QUESTIONED WHETHER THE ASSAY WAS "READING 'ARTIFACTUALLY' HIGH DUE TO RENAL FAILURE ALONE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTACT PTH, IRMA, 100T PARATHYROID HORMONE IMMUNOASSAY CEW NICHOLS INSTITUTE DIAGNOSTICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention