BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR

    MDR report key: 18419537 · Received December 29, 2023

    Report

    Report Number
    3016438761-2023-00696
    Event Type
    Malfunction
    Date Received
    December 29, 2023
    Date of Event
    December 19, 2023
    Report Date
    January 21, 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 TECHNICAL APPLICATION SPECIALIST (TAS) INSPECTED THE INSTRUMENT AND FOUND SAMPLE CRYSTALS ON THE OUTSIDE OF THE SAMPLE PIPETTING OPENING AND SURMISED THE CRYSTALS MAY HAVE FALLEN INTO THE REACTION VESSELS CAUSING ERRONEOUS RESULTS. THE TAS DETERMINED THE PIPETTOR AND THE LOAD/UNLOAD DIVERTER WERE THE LIKELY CAUSE OF THE ISSUE. THE TAS CLEANED THE PARTS TO RESOLVE THE ISSUE AND VERIFIED THE SYSTEM FUNCTION WITH A CONTROL RUN. AN INSTRUMENT SERVICE HISTORY WAS REVIEWED AND REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED FOR (B)(6). A REVIEW OF TRACKING AND TRENDING OF THE IMMUNOASSAY SYSTEMS DID NOT IDENTIFY ANY SIMILAR ISSUES RELATED TO THE ARCHITECT SYSTEM, LIKELY CAUSE PARTS, OR DISCREPANT RESULTS AS DESCRIBED IN THIS TICKET. THE DEVICE HISTORY RECORDS WERE REVIEWED, AND NO NON-CONFORMANCES OR DEVIATIONS WERE IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT I2000SR PROCESSING MODULE, SERIAL NUMBER (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT TOTAL HCG RESULT FOR ONE PATIENT. THE SAMPLE WAS REPEATED AND A NEGATIVE RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 182.38 MIU/ML (POSITIVE); REPEAT RESULT = < 1.2 MIU/ML (NEGATIVE) WHILE TROUBLESHOOTING THE ISSUE, THE TECHNICAL APPLICATION SPECIALIST (TAS) NOTICED SIGNIFICANT CRYSTALLIZATION ON THE PIPETTOR OPENING. IT IS SUSPECTED THAT THE CRYSTALLIZATION MAY HAVE CAUSED CONTAMINATION DURING TESTING RESULTING IN THE FALSE POSITIVE RESULT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT TOTAL -HCG RESULT FOR ONE PATIENT. THE SAMPLE WAS REPEATED AND A NEGATIVE RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 182.38 MIU/ML (POSITIVE); REPEAT RESULT = < 1.2 MIU/ML (NEGATIVE) WHILE TROUBLESHOOTING THE ISSUE, THE TECHNICAL APPLICATION SPECIALIST (TAS) NOTICED SIGNIFICANT CRYSTALLIZATION ON THE PIPETTOR OPENING. IT IS SUSPECTED THAT THE CRYSTALLIZATION MAY HAVE CAUSED CONTAMINATION DURING TESTING RESULTING IN THE FALSE POSITIVE RESULT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665606 ARCHITECT I2000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC BHCG RGT (2000T), 07K78-30, 51157UD00| ARC BHCG RGT (2000T), 07K78-30, 51157UD00