BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH REAGENT KIT

    MDR report key: 11223283 · Received January 25, 2021

    Report

    Report Number
    3002809144-2021-00054
    Event Type
    Malfunction
    Date Received
    January 25, 2021
    Date of Event
    December 18, 2020
    Report Date
    February 11, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    CEW
    PMA / PMN Number
    K063232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION WAS PERFORMED FOR OBSERVED ERRATIC / IMPRECISE RESULTS AND INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF THE COMPLAINT TEXT, TRENDING DATA, LABELING, DEVICE HISTORY RECORDS, AND HISTORICAL PERFORMANCE OF LOT 00120D000. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DETERMINED NO TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 00120D000 AND THE COMPLAINT ISSUE. THE HISTORICAL PERFORMANCE OF REAGENT LOT 00120D000 WAS EVALUATED USING WORLDWIDE DATA FROM ABBOTTLINK FOR THE ROUTINE ASSAY. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 00120D000 IS WITHIN THE ESTABLISHED CONTROL LIMITS, THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE OF ERRATIC / IMPRECISE RESULTS. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT INTACT PTH REAGENT, LOT NUMBER 00120D000, WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED BY THE CUSTOMER DUE TO PRIVACY ISSUES. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8K25-28 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8K25-29.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT IPTH RESULTS ON ONE PATIENT OVER THE COURSE OF ONE YEAR. THE RESULTS PROVIDED WERE: 359, 253, 363, 335, 161, 137, 363, 316, 208, (B)(6) 2020 =146PG/ML, (B)(6) 2021 = 120PG/ML(NORMAL RANGE 14-75PG/ML). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119162 ARCHITECT IPTH REAGENT KIT RADIOIMMUNOASSAY, PARATHYROID HORMONE CEW ABBOTT GMBH 00120D000

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC I1000SR MOD, 01L86-01, I1SR50975| ARC I1000SR MOD, 01L86-01, I1SR50975| ARC I1000SR MOD, 01L86-01, (B)(4)