BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 5501245 · Received March 15, 2016

    Report

    Report Number
    3002809144-2016-00013
    Event Type
    Malfunction
    Date Received
    March 15, 2016
    Report Date
    May 10, 2017
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CEW
    PMA / PMN Number
    K063232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 08K25-25, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08K25-27. (B)(4).

    Additional Manufacturer Narrative · 1

    NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE FOR THIS INVESTIGATION. THE INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, ACCURACY TESTING, A LITERATURE REVIEW, AND A REVIEW OF LABELING. A LOT SEARCH FOR REAGENT LOT 00615K000 DID NOT IDENTIFY ATYPICAL COMPLAINT ACTIVITY. ACCURACY TESTING WAS PERFORMED USING IN-HOUSE FILE SAMPLES OF REAGENT LOT 00615K000 AND MET ACCEPTANCE CRITERIA. 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 SIX DIFFERENT INTACT PARATHYROID HORMONE ASSAYS, INCLUDING THE ARCHITECT IPTH ASSAY, WHICH WAS THE COMPARISON METHOD. OVERALL, THE STUDY FOUND GOOD CORRELATION FOR ALL METHODS, BUT DID INDICATE THERE WAS SIGNIFICANT BIAS BETWEEN METHODS. THE STUDY CONCLUDED THAT THERE ARE MANY FACTORS THAT POTENTIALLY INFLUENCE VARIABILITY FOR PTH MEASUREMENTS AND THAT STANDARDIZATION EFFORTS ARE WARRANTED AND ASSAY-SPECIFIC DECISION LIMITS ARE REQUIRED. THE ARCHITECT INTACT PTH ASSAY PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE RESULTS OF THIS INVESTIGATION AND THE INFORMATION FROM THE CUSTOMER SITE, IT WAS DETERMINED THAT THE ARCHITECT IPTH ASSAY IS PERFORMING AS INTENDED AND NO PRODUCT DEFICIENCY/MALFUNCTION WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED; THEREFORE, THE DEVICE WAS NOT PERFORMING AS INTENDED AND THE EVALUATION CODES WERE CORRECTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS AN INCREASE IN THE NUMBER OF FALSELY ELEVATED ARCHITECT IPTH ASSAY RESULTS GENERATED FOR PATIENT SAMPLES TESTED ON THE ARCHITECT I1000SR ANALYZER. THE CUSTOMER PROVIDED THE FOLLOWING EXAMPLE: ARCHITECT IPTH ASSAY RESULTS: 157 AND 168 PG/ML. DIASORIN PTH RESULTS: 72 PG/ML. NO SUSPECT RESULTS HAVE BEEN REPORTED FROM THE LAB WITH NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158242 ARCHITECT IPTH INTACT PARATHYROID HORMONE CEW ABBOTT GERMANY 00615K000

    Patients

    Seq Age Sex Outcome Treatment
    1