BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 7763610 · Received August 8, 2018

    Report

    Report Number
    1628664-2018-01343
    Event Type
    Malfunction
    Date Received
    August 8, 2018
    Date of Event
    July 17, 2018
    Report Date
    August 14, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740001537
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) SERVICED THE ANALYZER ONSITE AND REPLACED THE VALVE, MANIFOLD KIT (PART # 7-77612-03) WHICH RESOLVED THE ISSUE. THERE HAVE BEEN NO SUBSEQUENT CONTACTS FROM THE CUSTOMER REGARDING DISCREPANT RESULTS SINCE THE PART WAS REPLACED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE ARCHITECT ANALYZER SERVICE HISTORY FOUND NO CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE COMPLAINT. A REVIEW FOR SIMILAR COMPLAINTS ASSOCIATED WITH THE VALVE KIT (PART # 7-77612-03) IDENTIFIED NO TRENDS REGARDING DISCREPANT PATIENT RESULTS. A REVIEW OF THE ARCHITECT I1000SR TRACKING AND TRENDING DATA REVEALED NO SYSTEMIC ISSUES AND NO TRENDS ASSOCIATED WITH THE ERRATIC RESULTS. THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS; AND TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM. THE OPERATIONS MANUAL ALSO ADDRESSES TROUBLESHOOTING OF ERROR CODES 1005, 1008, 1232, AND DEPRESSED CONCENTRATION AND ERRATIC SAMPLE RESULTS, INCLUDING THE TROUBLESHOOTING PERFORMED BY THE FSE. THE ARCHITECT I1000SR SERVICE AND SUPPORT MANUAL PROVIDES INSTRUCTIONS FOR REPLACING THE MANIFOLD KIT VALVES. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT SERIAL NUMBER (B)(4), OR THE VALVE, MANIFOLD KIT (PART # 7-77612-03).

    Additional Manufacturer Narrative · 1

    (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE IS NO FURTHER PATIENT INFORMATION PROVIDED DUE TO PRIVACY ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT HS TROPONIN RESULTS ON A PATIENT. THE CUSTOMER OBSERVED ERRORS 1005, 1008, 1232[RESULT CANNOT BE CALCULATED, RLU READ IS OUTSIDE THE SPECIFICATION OF THE LOWEST/HIGHEST CALIBRATOR, FINAL READ FAILURE.]. THE RESULTS THAT WERE MEASURED BETWEEN THE ERROR MESSAGES DID NOT CONFIRM: PID (B)(6) AT 8:34 PM = 0.0 (RLU = 36) NG/ML, ON DIFFERENT ANALYZER REPEAT = 61.5 NG/ML (DIAGNOSTIC CUTOFF = 26.2NG/ML). THERE WAS NO IMPACT ON PATIENT CARE AND NO UNNECESSARY TREATMENT GIVEN AS RESULTS WERE NOT REPORTED OUT FROM THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602420 ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740001537

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I,| ARCHITECT STAT HIGH SENSITIVE TROPONIN-I,| LIST # 03P25-26, LOT # 87140UI00| LIST #03P25-26, LOT # 87140UI00