BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TSH

    MDR report key: 3894986 · Received June 25, 2014

    Report

    Report Number
    3005094123-2014-00017
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 4, 2014
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A LABELING REVIEW IDENTIFIED THAT THERE ARE SUFFICIENT INSTRUCTIONS IN THE PRODUCT LABELING TO ASSIST THE CUSTOMER IN TROUBLESHOOTING THIS ISSUE. A REVIEW OF ALL COMPLAINTS ASSOCIATED WITH ARCHITECT TSH REAGENT LOT 37926UI00 WAS PERFORMED. THE REVIEW DID NOT IDENTIFY ANY ATYPICAL COMPLAINT ACTIVITY FOR ARCHITECT TSH REAGENT LOT 37926UI00. A REVIEW OF QUALITY RECORDS ASSOCIATED WITH ARCHITECT TSH REAGENT LOT 37926UI00 AND ALL ASSOCIATED SUB-LOT NUMBERS DEMONSTRATED THAT THERE HAVE BEEN NO KNOWN QUALITY ISSUES IN RELATION TO THIS PRODUCT SINCE MANUFACTURE. ACCURACY TESTING WAS PERFORMED USING ARCHITECT TSH REAGENT LOT 37926UI00. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET. THIS TESTING DEMONSTRATES THE ABILITY OF THE ARCHITECT TSH ASSAY TO PROVIDE ACCURATE RESULTS IN A PORTION OF THE DYNAMIC RANGE. IN SUMMARY, BASED ON THE INVESTIGATION PERFORMED, NO PRODUCT DEFICIENCY OR MALFUNCTION WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 STATED THAT THE ARCHITECT ANALYZER GENERATED A FALSELY DECREASED TSH RESULT ON ONE PATIENT SAMPLE. SID (B)(6) ON (B)(6) 2014 ON SERIAL NUMBER(B)(4) = 0.662 MIU/L; REPEATED ON (B)(6) 2014 ON SAME SERIAL NUMBER = 50.50 MIU/L AND ON A DIFFERENT ARCHITECT = 52.69 MIU/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371606 ARCHITECT TSH TSH JLW A.I.D.D LONGFORD 37926UI00

    Patients

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