BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR

    MDR report key: 17748211 · Received September 14, 2023

    Report

    Report Number
    3016438761-2023-00498
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    September 4, 2023
    Report Date
    September 14, 2023
    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

    DURING THE REQUESTED SITE VISIT, THE ABBOTT FIELD SERVICE ENGINEER (FSE) CLEANED THE SHUTTER (ROHS)_PART NUMBER 7-78200-02 WHICH RESOLVED THE ISSUE. A REVIEW OF THE (B)(6) SERVICE HISTORY WAS PERFORMED AND NO ADDITIONAL ERRATIC RESULTS PRE- OR POST THE CURRENT COMPLAINT WERE IDENTIFIED. THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS AND TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM. A REVIEW OF HISTORICAL DATA REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NONCONFORMANCES. THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS AND TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM AND COMPONENT REPLACEMENT, REMOVAL AND VERIFICATION OF THE PARTS. A REVIEW OF TRACKING AND TRENDING OF THE ARCHITECT I2000SR PROCESSING MODULE DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE SHUTTER. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ARCHITECT I2000SR, SN (B)(6), OR THE SHUTTER.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TROPONIN RESULT ON ONE FEMALE PATIENT. THE RESULT PROVIDED WERE: FIRST RESULT WITH SERIAL NUMBER (B)(6) /SECOND RESULTS WITH SERIAL NUMBER (B)(6) FROM SAME LOT NUMBER OF TROPONIN REAGENT. PATIENT 5: = 24.4 PG/ML /=2.0 PG/ML. LABORATORY REFERENCE RANGE FOR TROPONIN; FEMALE=0.0 TO 15.6 PG/ML; MEN=0.0 TO 34.2 PG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2282684 ARCHITECT I2000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 Female ARC I2000SR INST, 03M74-02, (B)(6)