BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000

    MDR report key: 12025257 · Received June 18, 2021

    Report

    Report Number
    3016438761-2021-00224
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Report Date
    July 23, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOCAL SERVICE REPRESENTATIVE WAS CONTACTED TO CHECK THE UPS ASSOCIATED WITH THIS TICKET. UPON INSPECTION, THE SERVICE REPRESENTATIVE OBSERVED LIQUID INSIDE THE UPS WHICH CAUSED THE LOSS OF GROUNDING. IN ADDITION, IT WAS NOTED THAT THE UPS WAS POSITIONED UNDER A COUNTER WHERE LAB PERSONNEL HANDLES LABORATORY LIQUIDS. IT IS ASSUMED THAT THE LIQUID(S) FROM THE COUNTER ABOVE WAS THE SOURCE OF THE LIQUID FOUND INSIDE THE UPS. A REVIEW OF THE ARCHITECT C PROCESSING MODULE, SERIAL NUMBER (B)(6) SERVICE HISTORY FOUND NO CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE COMPLAINT. A REVIEW OF 12 MONTHS OF COMPLAINT DATA DID NOT IDENTIFY ANY ADVERSE TRENDS OR ANY NON-STATISTICAL TRENDS OR ANY ATYPICAL COMPLAINT ACTIVITY ASSOCIATED WITH THIS DESCRIBED ISSUE. A REVIEW OF THE POLARIS UPS RT3000 USER MANUAL ALSO PROVIDED A SAFETY WARNING REGARDING THE USE OF THE UPS IN AN INDOOR ENVIRONMENT THAT IS TEMPERATURE AND HUMIDITY CONTROLLED AND FREE OF CONDUCTIVE CONTAMINANTS. THE ARCHITECT SYSTEM OPERATIONS MANUAL, PROVIDES ADEQUATE INFORMATION, REGARDING THE HAZARDS AND SAFETY WARNINGS ASSOCIATED WITH THE USE OF LIQUIDS AND LIQUID SPILLS AROUND ELECTRICAL CONNECTORS AND COMPONENTS, AS WELL AS THE USE OF UNGROUNDED EQUIPMENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE LIKELY CAUSE PART OR THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C PROCESSING MODULE, C801746 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE HOSPITAL ENGINEER RECEIVED ELECTRIC SHOCK WHEN TOUCH REAR METAL PANEL CLOSED TO REFRIGERATOR ON BACK SIDE OF ARCHITECT C8000 PROCESSING MODULE AT THE TIME TROUBLESHOOTING FOR ERROR MESSAGE 7514 TEMPERATURE ABOVE MAXIMUM RANGE ON ARCHITECT C8000 PROCESSING MODULE. THE HOSPITAL ENGINEER CHECKED THE UPS CONNECTED WITH ARCHITECT C8000 PROCESSING MODULE. THE HOSPITAL ENGINEER DETERMINED THE ISSUE WITH GROUND OF NON-ABBOTT UPS. HE DISCONNECTS THE UPS AND CONNECT C8000 PROCESSING MODULE TO WALL OUTLET. THERE WAS NO ISSUE WITH ARCHITECT C8000 PROCESSING MODULE AFTER DISCONNECTED FROM THE NON-ABBOTT UPS. THE HOSPITAL ENGINEER DID NOT SEEK ANY MEDICAL ATTENTION DUE TO THE ELECTRIC SHOCK. THERE WAS NO PATIENT INVOLVEMENT OR FACILITY DAMAGE REPORTED. THE HOSPITAL ENGINEER DID NOT SEEK ANY MEDICAL ATTENTION DUE TO THE ELECTRIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919299 ARCHITECT C8000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability