BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 5945657 · Received September 13, 2016

    Report

    Report Number
    1628664-2016-00232
    Event Type
    Malfunction
    Date Received
    September 13, 2016
    Date of Event
    August 24, 2016
    Report Date
    October 3, 2016
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE ENGINEER (FSE) ARRIVED AT THE CUSTOMER SITE AND INSPECTED THE ARCHITECT C16000 ANALYZER. THE FSE DETERMINED THE SOURCE OF THE LEAK BEING THE PERISTALTIC PUMP TUBING (LN 7-202464-01). THE CAUSE OF THE INSTRUMENT ERRORS WAS DETERMINED TO BE A DAMAGED AC/DC DRIVER BOARD (LN 7-202603-01), WHICH HAD EVIDENCE OF CHARRING AROUND ONE OF THE BOARD COMPONENTS. THE FSE REPLACED THE AC/DC DRIVER BOARD TO ADDRESS THE ERRORS BUT RETURNED THE FOLLOWING DAY AS THE ERRORS PERSISTED. IT WAS DETERMINED THAT THE NEW AC/DC DRIVER BOARD WAS DAMAGED AND HAD THE SAME APPEARANCE AS THE ORIGINAL BOARD. A THIRD BOARD WAS INSTALLED BUT ALSO FAILED IN A SIMILAR FASHION AS THE PREVIOUS TWO BOARDS. AFTER SIGNIFICANT TROUBLESHOOTING AND ELECTRICAL METERING DIFFERENT COMPONENTS ON THE SYSTEM, IT WAS DETERMINED THAT THE ORIGINAL LEAK FROM THE PERISTALTIC PUMP TUBING HAD DAMAGED THE VACUUM PUMP (LN 7-202560-01) LOCATED DIRECTLY BELOW. THE FSE DOCUMENTED THAT IT APPEARS THE DAMAGED VACUUM PUMP WAS DRAWING TOO MUCH CURRENT, WHICH THEN IN TURN LED TO DAMAGING THE AC/DC DRIVER BOARD. BOTH THE VACUUM PUMP AND THE AC/DC DRIVER BOARD WERE REPLACED TO RESOLVE THE ISSUE. NO RETURNS WERE REQUESTED FROM THE CUSTOMER SITE. PICTORIAL DOCUMENTATION PROVIDED BY THE FSE VERIFIED THE EVENT. SUBSEQUENT INSTRUMENT OPERATIONS WERE ACCEPTABLE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE ARCHITECT C16000 SYSTEM SERVICE AND SUPPORT MANUAL CONTAIN INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND FROM THE RESULTS OF THIS EVALUATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST A PRODUCT DEFICIENCY EXISTS. THE ISSUE WAS RESOLVED THROUGH STANDARD TROUBLESHOOTING PROCEDURES.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT A LEAK NEAR THE WASTE PUMP OF AN ARCHITECT C16000 ANALYZER. ALSO, THE CUVETTE WASHER WAS NOT RESPONDING AS EXPECTED AND THE CUSTOMER WAS UNABLE TO INITIALIZE THE INSTRUMENT INTO THE READY MODE. VARIOUS ERROR CODES (EC) WERE ALSO GENERATED: EC5623- ICT REFERENCE SOLUTION NOT ASPIRATED; EC3854- PROBE WASH PUMP TIMEOUT WHILE MOVING TO LOWER LIMIT; AND, EC5650 CUVETTE WASHER TIMEOUT WHILE MOVING TO UPPER LIMIT. AN ABBOTT FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND REPLACED RUPTURED HIGH CONCENTRATION WASTE TUBING. THERE WERE NO INJURIES OR EXPOSURES DUE TO THIS ISSUE. SUBSEQUENT TROUBLESHOOTING LEAD TO THE DISCOVERY OF A DAMAGED AC/DC DRIVER BOARD. THE CUSTOMER LATER MENTIONED AN "ELECTRICAL FIRE" ODOR COMING FROM THE ANALYZER EARLIER IN THE DAY. THE FSE INSTALLED A NEW AC/DC CONTROLLER BOARD, WHICH DID NOT RESOLVE THE ISSUE. EXAMINATION OF THE BOARD FOUND CHARRING AROUND ONE OF THE COMPONENTS. THIS WAS LIMITED TO THE AC/DC DRIVER BOARD ONLY. THE FSE RETURNED TO THE SITE THE FOLLOWING DAY. DURING TROUBLE SHOOTING, TWO ADDITIONAL AC/DC DRIVER BOARDS FAILED. A NEW AC/DC DRIVER BOARD WAS INSTALLED ALONG WITH TWO VACUUM PUMPS, A POWER HARNESS AND A NEW WASH CUP MAG PUMP. SUBSEQUENT INSTRUMENT OPERATIONS WERE ACCEPTABLE. IN EACH CASE, CHARRING OF COMPONENTS ON EACH AC/DC DRIVER BOARD WAS OBSERVED. THERE WERE NO INJURIES REPORTED AND NO DAMAGE TO THE SURROUNDING LAB ENVIRONMENT. EACH INSTANCE WAS RESTRICTED TO THE RESPECTIVE AC/DC DRIVER BOARD. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597323 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 BOARD, AC/DC DRIVER LN: (B)(4)