BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TSH REAGENT KIT

    MDR report key: 20332768 · Received September 30, 2024

    Report

    Report Number
    3005094123-2024-00503
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 8, 2024
    Report Date
    December 5, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    JLW
    UDI-DI
    00380740131142
    PMA / PMN Number
    K983442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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, DEVICE HISTORY RECORD REVIEW, FIELD DATA REVIEW, AND LABELING 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 SEARCH FOR SIMILAR COMPLAINTS FOR LOT 61389UD00 DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE ISSUE. THE TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TREND REGARDING COMMONALTIES FOR LOT NUMBER 61389UD00 AND ISSUE. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY RELATED NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT NUMBER 61389UD00 AND COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ALINITY I TSH WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. THE MEDIAN POPULATION RESULT FOR THE COMPLAINT LOT ARE WITHIN ESTABLISHED LIMITS, INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY IN THE FIELD. LABELLING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I TSH REAGENT LOT 61389UD00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    A1 - PATIENT IDENTIFIER: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TSH FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 0.32 TO 5 MUI/L): ON (B)(6)2024, SID (B)(6), INITIAL TSH RESULT= 2.63 MUI/L; UNABLE TO REPEAT DUE TO LOW SAMPLE VOLUME. HISTORICAL TSH RESULT (2023) = 5.018 MIU/L. OTHER SAMPLES COLLECTED FOR COMPARISON: ON (B)(6) 2024, SID (B)(6), INITIAL RESULT= 87.35 MUI/L. ON (B)(6) 2024, SID (B)(6), INITIAL RESULT= 94.7 MUI/L. ON (B)(6) 2024, SID (B)(6), INITIAL RESULT= 62.17 MUI/L. ON (B)(6)2024, SID (B)(6), INITIAL RESULT= 61.65 MUI/L . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TSH FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 0.32 TO 5 MUI/L): (B)(6)2024, SID (B)(6), INITIAL TSH RESULT= 2.63 MUI/L; UNABLE TO REPEAT DUE TO LOW SAMPLE VOLUME. HISTORICAL TSH RESULT (2023)= 5.018 MIU/L OTHER SAMPLES COLLECTED FOR COMPARISON: (B)(6)2024, SID (B)(6), INITIAL RESULT= 87.35 MUI/L, (B)(6)2024, SID(B)(6), INITIAL RESULT= 94.7 MUI/L, (B)(6)2024, SID (B)(6), INITIAL RESULT= 62.17 MUI/L, (B)(6)2024, SID(B)(6), INITIAL RESULT= 61.65 MUI/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963431 ALINITY I TSH REAGENT KIT RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ABBOTT IRELAND DIAGNOSTICS DIVISION 61389UD00 00380740131142

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)