BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR

    MDR report key: 20537484 · Received October 25, 2024

    Report

    Report Number
    3016438761-2024-00628
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    October 15, 2024
    Report Date
    November 18, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT, ARCHITECT I2000SR, SERIAL # (B)(6). THE FSR DETERMINED THE PIPETTOR Z-NUT (ROHS)_PART NUMBER 7-200015-01 THE LIKELY CAUSE AND REPLACED THE PART TO RESOLVE THE ISSUE. SERVICE VERIFIED THE SYSTEM FUNCTION WITH A CONTROL RUN. THE SERVICE HISTORY OF THE (B)(6)VERIFIES NO SUBSEQUENT FALSE ELEVATED FREE T4 RESULTS HAVE BEEN REPORTED. A REVIEW OF TRACKING AND TRENDING OF THE ALINITY I PROCESSING MODULE DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT I2000SR, SERIAL # (B)(6), WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED: TWO SAMPLES PROCESSED ON (B)(6) 2024: PATIENT 1 71-YEAR-OLD MALE INITIAL RESULT = 36.55 PMOL/L REPEAT RESULTS= 23 AND 17.15 PMOL/L. PATIENT 2 INITIAL RESULT = >64.35 PMOL/L REPEAT RESULT = 16.76 PMOL/L. REFERENCE RANGE = 9.01-19.05 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED: TWO SAMPLES PROCESSED ON (B)(6) 2024: PATIENT 1 71 YEAR OLD MALE INITIAL RESULT = 36.55 PMOL/L REPEAT RESULTS= 23 AND 17.15 PMOL/L. PATIENT 2 INITIAL RESULT = >64.35 PMOL/L REPEAT RESULT = 16.76 PMOL/L. REFERENCE RANGE = 9.01-19.05 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819051 ARCHITECT I2000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC FT4 2000T (CN), 07K65-77, 61272UD02| ARC FT4 2000T (CN), 07K65-77, 61272UD02| PIPETTOR Z-NUT (ROHS), 7-200015-01, UNKNOWN| PIPETTOR Z-NUT (ROHS), 7-200015-01, UNKNOWN