BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 10384894 · Received August 10, 2020

    Report

    Report Number
    3016438761-2020-00164
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 20, 2020
    Report Date
    August 24, 2020
    Manufacturer
    ABBOTT LABORATORIES (IRVING IA/CC)
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A SITE VISIT BY THE FIELD SERVICE ENGINEER (FSE) THE ANALYZER (ARCHITECT SN (B)(6) WAS INSPECTED AND THE FSE DISCOVERED THAT CHARRING OCCURRED TO THE CABLE OF THE RSH X-AXIS MOTOR WITH THE ENCODER DAMAGED. THE FSR REPLACED THE MOTOR, RSH X-AXIS, WITH ENCODER (ROHS) (LN: 7-202962-01) WHICH RESOLVED THE ISSUE. NO FIRE WAS OBSERVED, AND NO INJURY OCCURRED. A REVIEW OF THE SERVICE HISTORY FOR THE ARCHITECT (B)(6) ANALYZER REVEALED NO ADDITIONAL ISSUES WERE REPORTED. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE ARCHITECT ANALYZER OR THE ASSOCIATED PARTS. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND CONTAINS ADEQUATE INFORMATION REGARDING ELECTRICAL HAZARDS AND PERFORMING AN EMERGENCY SHUTDOWN OF THE ARCHITECT AS WELL AS TROUBLESHOOTING, REMOVAL AND REPLACEMENT OF THE INDICATED PARTS. THE CHARRING OBSERVED WAS LIMITED TO THE THE CABLE OF THE RSH X-AXIS MOTOR AND THE DAMAGE DID NOT SPREAD TO OTHER PARTS OF THE INSTRUMENT. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY 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

    CUSTOMER REPORT OF A STRONG BURNING SMELL EMANATING FROM THE ARCHITECT C4000 ANALYZER. ABBOTT FIELD SERVICE DISCOVERED THE RSH X-AXIS WITH ENCODER MOTOR CABLE IS DAMAGED AND BURNED. THIS PART IS NOT VISIBLE TO THE USER SINCE IT HAS A COVER ON IT. NO IMPACT TO USER SAFETY OR PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849194 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT LABORATORIES (IRVING IA/CC) 2P24-40 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1