BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TSH REAGENT KIT

    MDR report key: 20727326 · Received November 19, 2024

    Report

    Report Number
    3005094123-2024-00596
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    November 4, 2024
    Report Date
    January 27, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    JLW
    UDI-DI
    00380740162023
    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 7K62-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7K62, WITH 510K/PMA/BLA NUMBER K983442. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE COMPLAINT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS REGARDING COMMONALITIES FOR COMPLAINT LOT. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF THE ARCHITECT TSH REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN VALUES OBTAINED WITH THE COMPLAINT LOT 61378UD04 IS WITHIN ESTABLISHED LIMITS AND THUS COMPARABLE TO THE HISTORICAL LOT PERFORMANCE, WHICH CONFIRMS NO SYSTEMIC ISSUE FOR THE LOT. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT TSH REAGENT LOT 61378UD04 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT TSH. THE PHYSICIAN QUESTIONED WHY THE RESULT ON 4 NOV WAS LOWER AND A NEW SAMPLE WAS OBTAINED AND TESTED ON (B)(6). THE CUSTOMER PROVIDED THE FOLLOWING DATA: CUSTOMER REFERENCE: 0.35-4.94 UIU/ML (B)(6) SAMPLE INITIAL RESULT WAS 4.60 AND REPEAT RESULT WAS 4.45 (B)(6) SAMPLE INITIAL RESULT WAS 7.07 AND REPEAT RESULT WAS 7.10 THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT TSH. THE PHYSICIAN QUESTIONED WHY THE RESULT ON 4 NOV WAS LOWER AND A NEW SAMPLE WAS OBTAINED AND TESTED ON 11 NOV. THE CUSTOMER PROVIDED THE FOLLOWING DATA: CUSTOMER REFERENCE: 0.35-4.94 UIU/ML ON (B)(6) SAMPLE INITIAL RESULT WAS 4.60 AND REPEAT RESULT WAS 4.45 ON (B)(6) SAMPLE INITIAL RESULT WAS 7.07 AND REPEAT RESULT WAS 7.10 THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2307335 ARCHITECT TSH REAGENT KIT RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ABBOTT IRELAND DIAGNOSTICS DIVISION 61378UD04 00380740162023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, (B)(6)| ARC I2000SR INST, 03M74-02, (B)(6)