BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TSH REAGENT KIT

    MDR report key: 12480454 · Received September 16, 2021

    Report

    Report Number
    3005094123-2021-00176
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    September 9, 2021
    Report Date
    November 11, 2021
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    JLW
    UDI-DI
    00380740014247
    PMA / PMN Number
    K983442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE ARCHITECT TSH REAGENT LOT 28075UD00 IDENTIFIED NORMAL COMPLAINT ACTIVITY AND THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. HISTORICAL PERFORMANCE IN THE FIELD OF REAGENT LOT USING WORLDWIDE DATA THROUGH ABBOTTLINK WAS EVALUATED. THE MEDIAN POPULATION RESULT FOR THE LOT IS WITHIN ESTABLISHED BASELINES AND COMPARABLE WITH ALL OTHER LOTS IN THE FIELD AND CONFIRMS NO SYSTEMIC ISSUE FOR THIS LOT. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. THE PERFORMANCE OF THE LIKELY CAUSE LOT WAS INVESTIGATED BY COMPLETING A REVIEW FOR NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES AND DEVIATIONS RELATED TO THE LIKELY CAUSE LOT. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON OUR INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ARCHITECT TSH REAGENT LOT 28075UD00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT TSH RESULT ON A PATIENT. RESULTS PROVIDED: 09SEP2021 SID (B)(6)= 0.0055 MIU/L, REPEATED ON ANOTHER ARCHITECT = 0.9 MIU/ML. OTHER RESULTS ALSO PROVIDED: FT4 = 61.77 PMOL/L, ANOTHER ARCHITECT = 12.5 / 12.2 PMOL/L LH = 5.22 / 11.96 IU/L FSH = 6.26 / 4.37 IU/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378965 ARCHITECT TSH REAGENT KIT RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW A.I.D.D LONGFORD 7K62-30 28075UD00 00380740014247

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC I2000SR INST, 03M74-02, (B)(4).| ARC I2000SR INST, 03M74-02, (B)(4).| ARC I2000SR INST, 03M74-02, ISR08024