BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TSH

    MDR report key: 3841557 · Received May 30, 2014

    Report

    Report Number
    3005094123-2014-00015
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 9, 2014
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER ADDED, 35913UI00. AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. AN EVALUATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    THE COMPLETE ID IS (B)(6). (B)(4). A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. AN EVALUATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    A REVIEW OF ALL COMPLAINTS ASSOCIATED WITH THE ARCHITECT TSH LOT 35913UI00 WAS PERFORMED. NO ADVERSE TRENDS WERE IDENTIFIED FOR THE ISSUE PRESENTED IN THIS TICKET FOR THE ARCHITECT TSH ASSAY. A LABELING REVIEW IDENTIFIED THAT THERE ARE SUFFICIENT INSTRUCTIONS IN THE PRODUCT LABELING TO ASSIST THE CUSTOMER IN TROUBLESHOOTING THIS ISSUE. TESTING WAS CARRIED OUT USING AN ACCURACY PROCEDURE. ONE RUN WAS PERFORMED ON ONE ARCHITECT INSTRUMENT USING QUALITY FILE SAMPLES OF ARCHITECT TSH REAGENT LOT 35913UI00. CONTROLS AND PANELS WERE EVALUATED. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET. THIS TESTING DEMONSTRATES THE ABILITY OF THE ABBOTT ARCHITECT TSH ASSAY TO PROVIDE ACCURATE RESULTS IN A PORTION OF THE DYNAMIC RANGE. A REVIEW OF ALL NON-CONFORMANCE REPORTS AND DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LOT 35913UI00 AND ALL ASSOCIATED SUB-LOT NUMBERS DEMONSTRATED THAT THERE HAVE BEEN NO KNOWN QUALITY ISSUES IN RELATION TO THIS PRODUCT SINCE MANUFACTURE. A REVIEW OF THE TESTING DOCUMENTATION WAS PERFORMED AND DEMONSTRATED THAT THE ARCHITECT TSH REAGENT LOT 35913UI00 PASSED ALL THE REQUIRED SPECIFICATIONS AND WAS FOUND TO BE ACCEPTABLE. IN SUMMARY NO ADVERSE TRENDS, ATYPICAL COMPLAINT ACTIVITY, MALFUNCTION OR PRODUCT DEFICIENCY HAVE BEEN IDENTIFIED ASSOCIATED WITH ARCHITECT TSH LOT 35913UI00.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED FALSELY DEPRESSED ARCHITECT TSH RESULTS ON PLASMA SAMPLE ID (B)(6) THAT REPEATED HIGHER. INITIALLY, THE SAMPLE TESTED ARCHITECT TSH OF 27.6105 UIU/ML WHICH WAS REPORTED OUTSIDE OF THE LABORATORY. LATER THAT DAY, THE SAME SAMPLE WAS USED IN A CORRELATION STUDY WITH ARCHITECT TSH OF 0.9862 UIU/ML. NEXT, A SERUM SAMPLE FROM THE PATIENT TESTED ARCHITECT TSH OF 113 UIU/ML. A DILUTION STUDY WAS THEN PERFORMED WITH BOTH THE SERUM AND PLASMA SAMPLE WITH RESULTS OF 77, 79, 83, 81 UIU/ML. THE ARCHITECT TSH RESULT OF 77 UIU/ML WAS REPORTED OUTSIDE OF THE LABORATORY. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318387 ARCHITECT TSH TSH JLW A.I.D.D LONGFORD 35913UI00

    Patients

    Seq Age Sex Outcome Treatment
    1 SERIAL (B)(4)| SERIAL (B)(4)| ARCHITECT I2000SR, LIST 03M74-02| ARCHITECT I2000SR, LIST 03M74-02| ARCHITECT I2000SR, LIST 03M74-02| SERIAL (B)(4)