BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR

    MDR report key: 16139081 · Received January 11, 2023

    Report

    Report Number
    3016438761-2023-00015
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    October 14, 2022
    Report Date
    January 11, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3002809144-2023-00002-00 UNDER A DIFFERENT SUSPECT DEVICE. ABBOTT FIELD SERVICE (FS) INVESTIGATED THE ISSUE ON SITE. FS TROUBLESHOOTING INCLUDED REPLACING THE TRIGGER LEVEL SENSOR (WHICH WAS DETERMINED TO BE THE LIKELY CAUSE). THERE HAVE BEEN NO FURTHER REPORTS OF DISCREPANT RESULTS SINCE ABBOTT FS WAS ON-SITE. A REVIEW OF THE ARCHITECT I2000SR, SERIAL NUMBER (B)(4) SERVICE HISTORY WAS NOT ABLE TO IDENTIFY OR CONFIRM ANY ADDITIONAL LIKELY CAUSES. A REVIEW OF HISTORICAL DATA REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NON-CONFORMANCES. A REVIEW OF THE ARCHITECT IMMUNOASSAY SYSTEMS REVEALED FOUND NO SYSTEMIC ISSUES OR TRENDS FOR THE ISSUE ASSOCIATED WITH THIS TICKET (ERRATIC/DISCREPANT RESULTS). A REVIEW OF LABELLING ADEQUATELY ADDRESSES SAMPLE RESULTS OBSERVED PROBLEMS FOR ERRATIC / DISCREPANT RESULTS. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT I2000SR, SERIAL NUMBER (B)(4) ANALYZER. PATIENT IDENTIFIER COMPLETE SID : (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NONREACTIVE ARCHITECT HIV AG/AB COMBO RESULT ON A PATIENT. RESULTS PROVIDED: (B)(6) 2022 SID (B)(6) = 0.0 (NON-REACTIVE), REPEATED ON (B)(6) 2022 = 785.36 S/CO. NEW SAMPLE ON (B)(6) 2022 = 733.59 (REACTIVE), THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200239 ARCHITECT I2000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC HIV COMBO RGT 500T, 04J27-37, 44212BE00