BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-TPO REAGENT KIT

    MDR report key: 14211879 · Received April 26, 2022

    Report

    Report Number
    1415939-2022-00031
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    April 10, 2022
    Report Date
    June 22, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JZO
    PMA / PMN Number
    K052407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 2K47-25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K47-27. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSELY DECREASED ARCHITECT ANTI-TPO RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. THE COMPLAINT ACTIVITY WAS NORMAL FOR THE COMPLAINT ISSUE. THE TRACKING AND TRENDING WERE REVIEWED, AND NO RELATED TRENDS WERE IDENTIFIED. ACCURACY TESTING WAS COMPLETED USING A RETAINED KIT OF THE COMPLAINT LOT 15386UN21. INTERNAL PANELS WERE TESTED, AND ACCEPTANCE CRITERIA WERE MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. DEVICE HISTORY RECORD WAS REVIEWED AND DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, NON-CONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LOT. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY FOR ARCHITECT ANTI-TPO REAGENT LOT 15386UN21 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT TSH AND ARCHITECT ANTI-TPO RESULTS FOR A (B)(6) FEMALE UNDERWENT A HEALTH EXAMINATION ON (B)(6) 2022. THE FOLLOWING DATA WAS PROVIDED: SAMPLE NO. 14: ON (B)(6) 2022: TSH: 0.072, ANTI-TPO: 0.64. ON (B)(6) 2022, THE PATIENT SOUGHT MEDICAL ATTENTION AT THE CLINIC, HOWEVER NO TREATMENT WAS GIVEN. A NEW PATIENT SAMPLE WAS DRAWN, AND THE RESULTS WERE: TSH: 6.475, ANTI-TPO: 1012.36. RETEST SAMPLE FROM (B)(6) 2022: TSH: 7.866, ANTI-TPO: 887.53. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026365 ARCHITECT ANTI-TPO REAGENT KIT SYSTEM, TEST, THYROID AUTOANTIBODY JZO ABBOTT LABORATORIES 15386UN21

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female ARC I2000SR INST, 03M74-02, ISR60040| ARC I2000SR INST, 03M74-02, ISR60040