BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 6167703 · Received December 12, 2016

    Report

    Report Number
    3002809144-2016-00104
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    November 9, 2016
    Report Date
    April 27, 2017
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CEW
    UDI-DI
    00380740048471
    PMA / PMN Number
    K063232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THEREFORE, THE DEVICE WAS NOT PERFORMING AS INTENDED AT THE CUSTOMER SITE. HOWEVER NO SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS IDENTIFIED. (B)(4).

    Additional Manufacturer Narrative · 1

    CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. ACCURACY TESTING WAS COMPLETED TO EVALUATE THE ASSAY PERFORMANCE USING A FILE KIT OF REAGENT LOT 02416A000. ALL REPLICATES MET ACCEPTANCE CRITERIA AND THE TESTING PASSED. A STUDY WAS REVIEWED "PERFORMANCE CHARACTERISTICS OF SIX INTACT PARATHYROID HORMONE ASSAYS". SONIA L. LA'ULU, AND WILLIAM L. ROBERTS, MD, PHD. AM J CLIN PATHOL 2010;134:930-938, 2010. THIS STUDY LOOKED AT THE PERFORMANCE CHARACTERISTICS OF 6 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 THERE WAS SIGNIFICANT BIAS BETWEEN METHODS. THE STUDY ALSO CONCLUDED THAT THERE ARE MANY FACTORS THAT POTENTIALLY INFLUENCE VARIABILITY FOR PTH MEASUREMENTS, INCLUDING THE METHOD USED, PTH SOURCE (SYNTHETIC VS ENDOGENOUS), POPULATION EVALUATED, VITAMIN D STATUS, PREANALYTIC VARIABLES SUCH AS SAMPLE MATRIX, AND STORAGE TIME AND TEMPERATURE. 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. IN ADDITION, TECHNICAL BULLETIN TB 1000-2016 WAS REVIEWED WHICH INDICATES THAT THE ARCHITECT INTACT PTH CALIBRATORS AND CONTROLS WILL HAVE A REDUCED EXPIRATION DATE (SHELF LIFE) TO ADDRESS CALIBRATOR INSTABILITY. A STUDY PERFORMED IN APRIL 2014 USING ABBOTT INTACT PTH CALIBRATORS WITH REDUCED DATING SUPPORTS THE RETURN OF PRODUCT PERFORMANCE TO PRODUCT CLAIMS. SIMILAR OVERALL PERFORMANCE TO A COMPARISON ASSAY WAS OBSERVED IN 2014 AS WAS OBSERVED IN 2007. THE % BIAS WAS DETERMINED TO BE 30.2% (95% CONFIDENCE INTERVAL, -6.4 - 66.8) IN STAT METHOD AND 26.2% (95% CONFIDENCE INTERVAL, -9.4 -61.7) IN ROUTINE METHOD. THE ARCHITECT INTACT PTH ASSAY PACKAGE INSERT WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THIS INVESTIGATION A PRODUCT DEFICIENCY WAS NOT IDENTIFIED. IN ADDITION, THERE IS NOT ENOUGH INFORMATION TO REASONABLY SUGGEST A MALFUNCTION HAD OCCURRED SINCE LIMITED TROUBLESHOOTING WAS PERFORMED. ADDITIONALLY, THE PRODUCT CLAIM INDICATES A POSITIVE BIAS TO THE COMPARISON ASSAY. NO ADDITIONAL PRODUCT ISSUES WERE IDENTIFIED; NO FURTHER INVESTIGATION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT FALSELY ELEVATED ARCHITECT IPTH RESULTS WERE GENERATED ON 2 SAMPLES. SAMPLE 1: AN INITIAL RESULT OF 85.7 PG/ML WAS GENERATED. THE RESULT WAS QUESTIONED BY THE PHYSICIAN AND THE SAMPLE WAS SENT TO ANOTHER LAB WHICH GENERATED A RESULT OF 55 PG/ML. A PREVIOUS RESULT FOR THE PATIENT WAS 110 PG/ML BUT THAT SAMPLE WAS NOT SENT OUT FOR FURTHER TESTING. SAMPLE 2: AN INITIAL RESULT OF 68 PG/ML WAS GENERATED. THE SAMPLE WAS SENT TO ANOTHER LAB WHICH GENERATED A RESULT OF 49 PG/ML. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817234 ARCHITECT IPTH INTACT PARATHYROID HORMONE CEW ABBOTT GERMANY 02416A007 00380740048471

    Patients

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