BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TSH

    MDR report key: 6112836 · Received November 18, 2016

    Report

    Report Number
    3005094123-2016-00051
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    October 20, 2016
    Report Date
    April 24, 2017
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    JLW
    UDI-DI
    00380740014230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THEREFORE, THE DEVICE WAS NOT PERFORMING AS INTENDED.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT/SERIAL NUMBER WAS MANUFACTURED PRIOR TO UDI COMPLIANCE DATE; THEREFORE, ONLY A DI IS PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT WHEN USING ARCHITECT TSH, LIST NUMBER 7K62-25, REAGENT LOT 67139UI00, THEY OBSERVED FALSELY DEPRESSED RESULTS FOR ONE PATIENT. THE CUSTOMER TESTED THE SAMPLE FOR DILUTION LINEARITY AND THE RESULTS WERE WITHIN RANGE, WHICH INDICATES THAT THERE ARE NO INTERFERENTS PRESENT IN THE SAMPLE. THERE WAS NO PATIENT SAMPLE AVAILABLE TO ASSIST IN THE INVESTIGATION. A REVIEW OF COMPLAINTS DETERMINED THAT THERE IS NO UNUSUAL ACTIVITY FOR LOT 67139UI00 AND NO TREND FOR THIS ISSUE WAS FOUND. ACCURACY TESTING WAS COMPLETED USING A FILE KIT OF LOT NUMBER 67139UI00 AND ALL TESTING MET ACCEPTANCE CRITERIA. A SEARCH FOR ANY ISSUES DURING MANUFACTURING OF THE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THIS COMPLAINT. THE ARCHITECT TSH PACKAGE INSERT PROVIDES INFORMATION FOR SAMPLE HANDLING ALONG WITH THE SPECIMEN COLLECTION AND LIMITATIONS IN THE INTERPRETATION OF RESULTS SECTION. THERE IS NOT ENOUGH EVIDENCE TO REASONABLY SUGGEST A MALFUNCTION AS THE ACCURACY TESTING CONFIRMS THAT THE PRODUCT IS PERFORMING ACCEPTABLY AND THE PATIENT RESULTS FROM THE ARCHITECT ARE WITHIN THE ACCEPTABLE RANGE AS PER LABELING. BASED ON ALL AVAILABLE INFORMATION AND THIS INVESTIGATION, THE ARCHITECT TSH LIST NUMBER 7K62-25, REAGENT 67139UI00, PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. UDI: (B)(4) LOT/SERIAL NUMBER WAS MANUFACTURED PRIOR TO UDI COMPLIANCE DATE; THEREFORE, ONLY A DI IS PROVIDED

    Additional Manufacturer Narrative · 1

    CATALOG # FROM THE INCORRECT 07K62-25 TO THE CORRECT 07K62-35. ALSO UPDATE THE MANUFACTURER'S NARRATIVE BELOW TO CORRECT THE CATALOG NUMBER. THE CUSTOMER STATED THAT WHEN USING ARCHITECT TSH, LIST NUMBER 7K62-35, REAGENT LOT 67139UI00, THEY OBSERVED FALSELY DEPRESSED RESULTS FOR ONE PATIENT. THE CUSTOMER TESTED THE SAMPLE FOR DILUTION LINEARITY AND THE RESULTS WERE WITHIN RANGE, WHICH INDICATES THAT THERE ARE NO INTERFERENTS PRESENT IN THE SAMPLE. THERE WAS NO PATIENT SAMPLE AVAILABLE TO ASSIST IN THE INVESTIGATION. A REVIEW OF COMPLAINTS DETERMINED THAT THERE IS NO UNUSUAL ACTIVITY FOR LOT 67139UI00 AND NO TREND FOR THIS ISSUE WAS FOUND. ACCURACY TESTING WAS COMPLETED USING A FILE KIT OF LOT NUMBER 67139UI00 AND ALL TESTING MET ACCEPTANCE CRITERIA. A SEARCH FOR ANY ISSUES DURING MANUFACTURING OF THE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THIS COMPLAINT. THE ARCHITECT TSH PACKAGE INSERT PROVIDES INFORMATION FOR SAMPLE HANDLING ALONG WITH THE SPECIMEN COLLECTION AND LIMITATIONS IN THE INTERPRETATION OF RESULTS SECTION. THERE IS NOT ENOUGH EVIDENCE TO REASONABLY SUGGEST A MALFUNCTION AS THE ACCURACY TESTING CONFIRMS THAT THE PRODUCT IS PERFORMING ACCEPTABLY AND THE PATIENT RESULTS FROM THE ARCHITECT ARE WITHIN THE ACCEPTABLE RANGE AS PER LABELING. BASED ON ALL AVAILABLE INFORMATION AND THIS INVESTIGATION, THE ARCHITECT TSH LIST NUMBER 7K62-35, REAGENT 67139UI00, PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. UDI: (B)(4) LOT/SERIAL NUMBER WAS MANUFACTURED PRIOR TO UDI COMPLIANCE DATE; THEREFORE, ONLY A DI IS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED FALSELY DECREASED TSH RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: (B)(6) ON (B)(6) 2016, TSH = 0.66IU/ML / FT4 = 0.7 / FT3 = 3.0; TESTED ON THE ROCHE COBAS TSH = 10.7MIU/ML. SAME SAMPLE RETESTED ON (B)(6) 2016 - ARCH TSH = 0.71 IU/ML / ROCHE = >10UIU/ML. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763179 ARCHITECT TSH TSH JLW A.I.D.D LONGFORD 67139UI00 00380740014230

    Patients

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