BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR

    MDR report key: 19166776 · Received April 23, 2024

    Report

    Report Number
    3016438761-2024-00227
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    April 4, 2024
    Report Date
    May 1, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740001537
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED TROUBLESHOOTING ON THE ARCHITECT I1000SR, SERIAL NUMBER (B)(6). AND DETERMINED THE VALVE, BYPASS, 2 WAY (ROHS) AND VALVE, MANIFOLD KIT (ROHS) WERE CLOGGED/OBSTRUCTED. BOTH THE VALVE, BYPASS, 2 WAY (ROHS)_PART NUMBER 7-200607-01 AND VALVE, MANIFOLD KIT (ROHS)_PART NUMBER 7-77612-04 WERE DEEMED THE LIKELY CAUSE AND BOTH PARTS WERE REPLACED TO RESOLVE THE ISSUE THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL SERVICE TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC PATIENT RESULTS. THERE WERE NO ADDITIONAL SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF TRACKING AND TRENDING DATA IN THE PRODUCT MONITORING REVIEW REVEALED NO SYSTEMIC ISSUES OR TRENDS RELATED TO THE RESULT ISSUE DESCRIBED IN THIS COMPLAINT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE ARCHITECT I1000SR AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT I1000SR, SERIAL NUMBER (B)(6). , VALVE, BYPASS, 2 WAY (ROHS)_PART NUMBER 7-200607-01 OR THE VALVE, MANIFOLD KIT (ROHS)_PART NUMBER 7-77612-04. THE INITIAL REPORT WAS SUBMITTED UNDER MANUFACTURER REPORT NUMBER 3005094123-2024-00181-01(A.I.D.D LONGFORD, LONGFORD AS MANUFACTURING SITE) WITH SUSPECT MEDICAL DEVICE OF ARCHITECT FREE T4, LIST 07K65-29. AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED ON 17APR2024 TO ARCHITECT I1000 PROCESSING MODULE, LIST 1L86 (IRVING, TX AS MANUFACTURING SITE), WHICH IS UNDER THIS REPORT.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THE INITIAL REPORT WAS SUBMITTED UNDER MANUFACTURER REPORT NUMBER 3005094123-2024-00181-01(A.I.D.D LONGFORD, LONGFORD AS MANUFACTURING SITE) WITH SUSPECT MEDICAL DEVICE OF ARCHITECT FREE T4, LIST 07K65-29. AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED ON (B)(6) 2024 TO ARCHITECT I1000 PROCESSING MODULE, LIST 1L86 (IRVING, TX AS MANUFACTURING SITE), WHICH IS UNDER THIS REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR ONE PATIENT. THE RESULT WAS LOWER WHEN THE SAMPLES WERE REPEATED. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT SID (B)(6) PROCESSED 04APR2024 = >5 NG/DL REPEAT RESULTS = 1.42 AND 1.03 NG/ML REFERENCE RANGE = 0.70 -1.48 NG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR ONE PATIENT. THE RESULT WAS LOWER WHEN THE SAMPLES WERE REPEATED. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT SID (B)(6) PROCESSED (B)(6) 2024 = >5 NG/DL REPEAT RESULTS = 1.42 AND 1.03 NG/ML. REFERENCE RANGE = 0.70 -1.48 NG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329774 ARCHITECT I1000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740001537

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC FT4 RGT KIT 100 TES, 07K65-29, (B)(6). | ARC FT4 RGT KIT 100 TES, 07K65-29, (B)(6).