BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR

    MDR report key: 17670246 · Received September 1, 2023

    Report

    Report Number
    3016438761-2023-00466
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    February 28, 2023
    Report Date
    September 1, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740116941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 1628664-2023-00002 UNDER THE SAME SUSPECT MEDICAL DEVICE BUT AN INCORRECT MANUFACTURER NAME, CITY AND STATE. COMPLETED INFORMATION FOR SECTION A1 PATIENT IDENTIFICATION: (B)(6). A REVIEW OF THE INSTRUMENT LOGS FOUND THE FOLLOWING ERROR CODES WERE GENERATED AROUND THE TIME THE SAMPLE IN QUESTION WAS PROCESSED: 0302 UNABLE TO PROCESS TEST, HARDWARE FAILURE OR THE USER PRESSED STOP. 3350 UNABLE TO PROCESS TEST, ASPIRATION ERROR FOR (PIPETTER) AT (SH SAMPLE). 3368 ASPIRATION ERROR ON LIQUID LEVEL SENSE BOARD (0), SHAPE CONFORM SCORE. THE CUSTOMER CALIBRATED THE SAMPLE PROBE AS INSTRUCTED/SUGGESTED TO RESOLVE THE ISSUE. THE SAMPLE ARC, PROBE WAS DEEMED THE LIKELY CAUSE FOR THE FALSE ELEVATED TROPONIN RESULTS. LABELING WAS REVIEWED AND PROVIDES ADEQUATE INFORMATION REGARDING THE TROUBLESHOOTING OF ERRATIC/DISCREPANT RESULTS. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL SERVICE TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC RESULTS. A REVIEW OF HISTORICAL DATA FOUND NO NON-CONFORMANCES RELATED TO THE CURRENT COMPLAINT. A REVIEW OF TRACKING AND TRENDING FOR THE ARC, PROBE DID NOT IDENTIFY ANY TRENDS. A REVIEW OF THE SCORECARD IDENTIFIED NO SIMILAR ISSUES RELATED TO THE ARCHITECT I1000SR OR LIKELY CAUSE PARTS AS DESCRIBED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY FOR THE ARCHITECT I1000SR PROCESSING MODULE, SN (B)(6) OR ARC, PROBE WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT STAT TROPONIN-I RESULTS GENERATED ON THE ARCHITECT I1000SR PROCESSING MODULE FOR ONE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR CLOSE MONITORING. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED NORMAL REFERENCE RANGE 0.0-0.03 NG/ML). (B)(6) INITIAL SAMPLE RESULT = 0.084 NG/ML. (B)(6) REDRAW RESULT = 0 NG/ML. (B)(6) SECOND REDRAW RESULT = 0 NG/ML. (B)(6) 3350 UNABLE TO PROCESS TEST, ASPIRATION ERROR. (B)(6) 0.002 NG/ML. (B)(6) 0 NG/ML. (B)(6) 0.008 NG/ML. (B)(6) 0 NG/ML. (B)(6) 0 NG/ML. (B)(6) 0.014 NG/ML. (B)(6) 0 NG/ML. (B)(6) 0 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190214 ARCHITECT I1000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740116941

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown