BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 3875161 · Received June 16, 2014

    Report

    Report Number
    3002809144-2014-00138
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CEW
    PMA / PMN Number
    K063232
    Removal / Correction Number
    3002809144-02/13/14-001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ABBOTT HAS CONFIRMED THAT A PERFORMANCE SHIFT IN THE ARCHITECT INTACT PTH ASSAY HAS THE POTENTIAL TO GENERATE FALSELY ELEVATED RESULTS ON PATIENT SAMPLES. A PRODUCT RECALL HAS BEEN ISSUED AND THE INVESTIGATION HAS IDENTIFIED INSTABILITY OF THE ARCHITECT INTACT PTH CALIBRATORS TO BE A MAJOR CONTRIBUTOR TO THE OBSERVED INCREASE IN PATIENT SAMPLE VALUES. AS OF (B)(4) 2014, REDUCED EXPIRATION DATING HAS BEEN IMPLEMENTED FOR THE REST OF WORLD (ROW) ARCHITECT INTACT PTH CALIBRATORS (LIST NUMBER 8K25-01 STARTING WITH LOT 03214C000) TO CORRECT THE ISSUE. ARCHITECT INTACT PTH CONTROLS (LIST NUMBER 8K25-10 STARTING WITH LOT 03114C000) ARE MANUFACTURED FROM THE SAME MATRIX MATERIAL AS THE CALIBRATORS. THEREFORE, BOTH ROW ARCHITECT INTACT PTH CALIBRATORS AND CONTROLS LISTED ABOVE WILL HAVE A REDUCED EXPIRATION DATING. IMPLEMENTATION OF ARCHITECT INTACT PTH CALIBRATORS AND CONTROLS WITH REDUCED EXPIRATION DATE (SHELF LIFE) WILL RETURN THE PRODUCT PERFORMANCE TO PACKAGE INSERT CLAIMS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT IPTH RESULTS GENERATED FROM ONE PEDIATRICS PATIENT. NO SPECIFIC PATIENT DATA WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER ALSO REPORTED THAT A PARATHYROID SURGICAL PROCEDURE WAS PERFORMED ON THE PATIENT DUE TO THE ULTRASOUND RESULTS REVIEWED BY THE PATIENT MEDICAL STAFF. THE CUSTOMER CONFIRMED THAT THE SURGICAL PROCEDURE WAS NECESSARY BASED ON THE ULTRASOUND RESULTS REGARDLESS OF THE IPTH VALUES. NO IMPACT OR FURTHER OUT-COMES TO THE PATIENT HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352010 ARCHITECT IPTH INTACT PARATHYROID HORMONE CEW ABBOTT GERMANY

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR 03M74-02, SN (B)(4)