BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 2935573 · Received January 30, 2013

    Report

    Report Number
    3002809144-2013-00008
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 23, 2013
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, ACCURACY TESTING, A STUDY REVIEW, REVIEW OF RELEASE TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. ACCURACY TESTING WAS PERFORMED USING A RETAINED SAMPLE OF THE SAME LOT OF REAGENT THE CUSTOMER WAS USING, AND PASSED. A STUDY WAS REVIEWED TITLED: "PERFORMANCE CHARACTERISTICS OF SIX INTACT PARATHYROID HORMONE ASSAYS". THE REVIEW INDICATED THAT WHILE THE ARCHITECT IPTH ASSAY SHOWED A POSITIVE BIAS, IT CORRELATED WELL AGAINST THE ROCHE MODULE E170. FOUR OTHER ASSAYS WERE ALSO EVALUATED AGAINST THE E170 AND ALL CORRELATED WELL. A REVIEW OF RELEASE TESTING WHICH INCLUDED THE TRENDING OF HUMAN SERUM/PLASMA PANELS, TESTED AS PART OF PRODUCT RELEASE TESTING, DEMONSTRATE THE ASSAY HAS NOT SHIFTED OVER THIS PERIOD OF TIME. TRACKING AND TRENDING IDENTIFIED NO ADVERSE TRENDS RELATED TO THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    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 AN INVESTIGATION IS ONGOING TO IDENTIFY THE CAUSE OF THE ISSUE. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ABBOTT HAS IDENTIFIED INSTABILITY OF THE ARCHITECT INTACT PTH CALIBRATORS TO BE A MAJOR CONTRIBUTOR TO THE OBSERVED INCREASE IN PATIENT SAMPLE VALUES. REDUCED EXPIRATION DATING HAS BEEN IMPLEMENTED TO ADDRESS THE ISSUE. ARCHITECT INTACT PTH CONTROLS ARE MANUFACTURED FROM THE SAME MATRIX MATERIAL AS THE CALIBRATORS. THEREFORE, BOTH ARCHITECT INTACT PTH CALIBRATORS AND CONTROLS WILL HAVE A REDUCED EXPIRATION DATING.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER GENERATED FALSELY ELEVATED IPTH FOR TWO SAMPLES FROM ONE PATIENT. THE FIRST SAMPLE WAS DRAWN ON (B)(6) 2013 AND GENERATED AN IPTH RESULT OF 1117.7 USING REAGENT LOT 02112E000. THE SAMPLE WAS REPEATED ON (B)(6) 2013 AND CONFIRMED. ON (B)(6) 2013 A NEW SAMPLE FROM THE SAME PATIENT WAS DRAWN AND IPTH RESULTS OF 1618.1 AND 1497.3 WERE GENERATED USING REAGENT LOT 01212G000. ALL OF THE RESULTS WERE QUESTIONED AS BEING TOO HIGH. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40175 ARCHITECT IPTH INTACT PARATHYROID HORMONE CEW ABBOTT GERMANY 01212G000

    Patients

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