BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH ASSAY

    MDR report key: 3853936 · Received June 6, 2014

    Report

    Report Number
    3002809144-2014-00135
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    September 11, 2012
    Report Date
    December 13, 2013
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF THE STUDY "PERFORMANCE CHARACTERISTICS OF SIX INTACT PARATHYROID HORMONE ASSAYS", AND A REVIEW OF LABELING. TRACKING AND TRENDING IDENTIFIED NO ATYPICAL COMPLAINT ACTIVITY. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE PERFORMANCE STUDY FOUND GOOD CORRELATION BETWEEN THE ARCHITECT IPTH AND COMPARATIVE METHODS. NO PRODUCT DEFICIENCY OR MALFUNCTION WAS IDENTIFIED. THIS EVENT WAS ORIGINALLY REPORTED IN MANUFACTURER REPORT NUMBER 3002809144-2014-00003.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT IPTH ASSAY RESULT. A VALUE OF 131 NG/L WAS GENERATED ON AN ARCHITECT I2000 ANALYZER. THE SAMPLE GENERATED A RESULT OF 89 PG/ML ON THE BECKMAN DXI PLATFORM. NO SUSPECT RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332691 ARCHITECT IPTH ASSAY PTH CEW ABBOTT GERMANY 03212E000

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR ARCHITECT I2000 ANALYZER,| LN 08C89-01 SN (B)(4)