BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 3000039 · Received March 12, 2013

    Report

    Report Number
    3002809144-2013-00075
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CEW
    PMA / PMN Number
    K063232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS ORIGINALLY FILED UNDER MANUFACTURE REPORT NUMBER: 1415939-2013-00080. THIS REPORT WAS OPENED TO DOCUMENT THE CORRECT MANUFACTURE LOCATION. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08K25-25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08K25-27. (B)(4).

    Additional Manufacturer Narrative · 1

    ACCURACY TESTING WAS PERFORMED ACROSS THREE ARCHITECT ISYSTEMS ANALYZERS TO EVALUATE REAGENT LOT 02112E000 USING IN-HOUSE FILE SAMPLES IN REGARDS ASSAY PERFORMANCE. THE TESTING PASSED WITH ALL RESULTS FALLING WITHIN SPECIFICATIONS. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. A STUDY WAS REVIEWED, PERFORMANCE CHARACTERISTICS OF SIX INTACT PARATHYROID HORMONE ASSAYS, SONIA L. LAULU, AND WILLIAM L. ROBERTS, MD, PHD. AM J CLIN PATHOL 2010;134:930-938, 2010. THIS STUDY LOOKED AT THE PERFORMANCE CHARACTERISTICS OF SIX INTACT PARATHYROID HORMONE ASSAYS, INCLUDING THE ARCHITECT, WHICH WAS THE COMPARISON METHOD. FOR METHOD COMPARISON, SERUM AND EDTA PLASMA SAMPLES WERE TESTED BY ALL METHODS. OVERALL, THE STUDY FOUND GOOD CORRELATION FOR ALL METHODS, BUT DID INDICATE A SIGNIFICANT BIAS BETWEEN METHODS. THE STUDY ALSO CONCLUDED THAT THERE ARE MANY FACTORS THAT POTENTIALLY INFLUENCE VARIABILITY FOR PTH MEASUREMENTS. THE STUDY ASSESSED SOME OF THESE FACTORS THAT CAN PRODUCE VARIABILITY AND CONFIRMED THAT THERE IS VARIABILITY BETWEEN PTH ASSAYS. IN CONCLUSION THE STUDY INDICATED THAT STANDARDIZATION EFFORTS ARE WARRANTED AND ASSAY-SPECIFIC DECISION LIMITS ARE REQUIRED. MANUFACTURING RELEASE TESTING WAS REVIEWED AND FOUND THAT THE ASSAY HAS NOT SHIFTED OVER A FOUR YEAR PERIOD OF TIME. THE ARCHITECT IPTH ASSAY PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. THE RESULTS OF THE CURRENT EVALUATION DEMONSTRATED THAT THE ARCHITECT IPTH ASSAY, LOT 02112E000, IS PERFORMING ACCEPTABLY. NO PRODUCT ISSUES WERE FOUND. A PRODUCT MALFUNCTION WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS FALSELY ELEVATED ARCHITECT INTACT PTH (IPTH) ASSAY RESULTS. ONE PATIENT GENERATED A RESULT OF 80.9 PG/ML. THE SAMPLE WAS THEN TESTED BY AN RIA METHODOLOGY AND GENERATED A RESULT OF 48.4 PG/ML. THE CUSTOMER IS CONCERNED THAT EVEN THOUGH THE ARCHITECT IPTH ASSAY HAS THE SAME REFERENCE RANGE AS THE RIA METHOD THAT THE ARCHITECT RESULTS HAVE SUCH A HIGH BIAS. THE CUSTOMER ALSO EXPRESSED CONCERN THAT EXTERNAL PROFICIENCY TEST RESULTS SHOW THAT THE ARCHITECT IPTH ASSAY IS NOT IN LINE WITH ANY COMPETITOR ASSAY AND DEMONSTRATES A VERY HIGH BIAS. NO SUSPECT RESULTS HAVE BEEN REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103003 ARCHITECT IPTH CEW ABBOTT GERMANY 02112E000

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR LN: 01L86-01| ARCHITECT I1000SR LN: 01L86-01| SN: (B)(4)| SN: (B)(4)