BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 5964195 · Received September 20, 2016

    Report

    Report Number
    3002809144-2016-00081
    Event Type
    Malfunction
    Date Received
    September 20, 2016
    Report Date
    October 19, 2016
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CEW
    PMA / PMN Number
    K063232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 8K25-25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8K25-27.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT THE ARCHITECT INTACT PTH ASSAY RESULTS WERE ELEVATED WHEN TESTING PATIENT RESULTS. A REVIEW OF COMPLAINT REPORTS RECEIVED TO DATE IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR THIS ISSUE. ACCURACY TESTING WAS PERFORMED WITH A FILE KIT OF LOT 00415I000 AND ALL RESULTS MET ACCEPTANCE CRITERIA. THE CUSTOMER WAS REFERRED TO A STUDY, "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 FOR ADDITIONAL INFORMATION. THE ARCHITECT INTACT PTH PACKAGE INSERT WAS REVIEWED AND THE CUSTOMER WAS DIRECTED TO THE "LIMITATIONS OF THE PROCEDURE" SECTION AND ALSO THE "EXPECTED VALUES" SECTION. PER LABELING THE PRODUCT CLAIM INDICATES A POSITIVE BIAS TO THE COMPARISON ASSAY. THERE WAS NO PRODUCT DEFICIENCY IDENTIFIED FOR THIS ISSUE. IN ADDITION, THERE IS NOT ENOUGH INFORMATION TO REASONABLY SUGGEST A MALFUNCTION HAD OCCURRED. BASED ON THIS INVESTIGATION IT HAS BEEN DETERMINED THAT THE ARCHITECT INTACT PTH ASSAY, LOT 00451I000 IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED FALSELY ELEVATED IPTH RESULTS ON EDTA SAMPLES STORED AT -20 C. PHYSICIANS COMMENTED THESE RESULTS COULD NOT BE CORRECT SO THE SITE SENT THE SAMPLES TO ANOTHER LAB WHERE THE RESULTS GENERATED WERE CLOSER TO PATIENT CLINICAL HISTORY. SAMPLES WERE PROCESSED BETWEEN (B)(6) 2016 WITH THE MEAN BEING 84.5PG/ML (NORMAL = 35 PG/ML). THE SITE PERFORMED A REGRESSION AND SAW A DIFFERENCE OF 40% IN ALL CASES. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614766 ARCHITECT IPTH INTACT PARATHYROID HORMONE CEW ABBOTT GERMANY 00415I000

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR ANALYZER, LIST # 01L86-01,| SERIAL # (B)(4)