BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 3984082 · Received August 6, 2014

    Report

    Report Number
    3002809144-2014-00161
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    June 30, 2013
    Report Date
    June 6, 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
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ARCHITECT INTACT PTH, LN 08K25-25, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, ARCHITECT INTACT PTH, LN 08K25-27. 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 (B)(6) 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 ACCOUNT STATED ONE PATIENT HAD ELEVATED ARCHITECT IPTH RESULTS A YEAR AGO WHICH LEAD TO ADDITIONAL MEDICAL EXAMS AND TESTING. NO SPECIFIC TESTING DATA OR PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459321 ARCHITECT IPTH INTACT PARATHYROID HORMONE CEW ABBOTT GERMANY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR LIST 03M74-97| SERIAL (B)(4)