BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2013136 · Received March 10, 2011

    Report

    Report Number
    1628664-2011-00104
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S UNINTERRUPTED POWER SUPPLY (UPS) FAILED, AND ABBOTT CUSTOMER SUPPORT ADVISED THE CUSTOMER TO BY-PASS THE UPS BY USING THE ELECTRONIC BY-PASS ON THE UPS. INSTEAD OF FOLLOWING THESE INSTRUCTIONS, THE CUSTOMER PHYSICALLY BY-PASSED THE UPS POWER BY CONNECTING DIRECTLY TO THE MAIN POWER WITH AN INAPPROPRIATE CONFIGURATION, WHICH DISCONTINUED POWER TO THE WASTE PUMP THAT THEN OVERFLOWED LIQUID THAT CAME INTO CONTACT WITH THE CABLE COUPLINGS OF DAISY CHAINED 13 AMP POWER CABLES SITTING ON THE FLOOR. THE CUSTOMER'S CIRCUIT BREAKERS DID NOT FUNCTION AS EXPECTED AND POWER CONTINUED TO THE 13 AMP POWER CABLES WHICH CAUSED THE BANG AND FLAMES (FOLLOW-UP CLARIFICATION FROM ABBOTT FIELD SERVICE INDICATES THE WORD "FLAME" WAS USED BY THE CUSTOMER TO DESCRIBE AN ELECTRICAL FLASH RATHER THAN A BURNING COMPONENT; NO EVIDENCE OF THERE BEING A FLAME OR FIRE WAS SEEN). 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 (PN 201837-108, JANUARY, 2010) CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. THE INCIDENT WAS CAUSED BY USER ERROR. THE CUSTOMER DID NOT FOLLOW INSTRUCTIONS GIVEN BY ABBOTT TO BYPASS THE UPS. THERE IS NO INDICATION THAT THE ARCHITECT I2000SR ANALYZER CONTRIBUTED TO OR CAUSED THE ISSUE. A PRODUCT MALFUNCTION WAS NOT IDENTIFIED. METHOD: FIELD SERVICE INTERVENTION; REVIEW OF COMPLAINT TRACKING AND TRENDING.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT WHEN THEY BYPASSED THE UNINTERRUPTED POWER SUPPLY (UPS) CONNECTED TO THE ARCHITECT I2000SR ANALYZER (THE UPS BATTERY POWER HAD FAILED) AND OPERATED THE ANALYZER FROM THE MAIN POWER SUPPLY THE POWER CABLE SHORTED OUT CAUSING A "BANG" AND FLAMES/ELECTRICAL ARCING. THE CUSTOMER NOTICED THAT THE CABLE WAS SITTING IN A PUDDLE OF LIQUID THAT SEEMED TO BE LEAKING FROM THE ANALYZER'S EXTERNAL WASTE PUMP. THERE ARE NO REPORTS OF ANY INJURIES TO LAB PERSONNEL. A SERVICE CALL HAS BEEN INITIATED. AN ABBOTT FIELD SERVICE ENGINEER (FSE) ARRIVED AT THE CUSTOMER SITE AND FOUND THAT THE ANALYZER HAD BEEN COMPLETELY DISCONNECTED FROM ELECTRICAL POWER. THE FSE FOUND THAT THE SUMP PUMP HAD NO POWER RUNNING TO IT, WHICH IN TURN CAUSED THE SUMP PUMP TO OVERFLOW AND ALLOWED LIQUID TO ENTER AN ELECTRICAL COUPLING. IT WAS DISCOVERED THAT THE CUSTOMER HAD MADE THEIR OWN MODIFICATION TO A 13 AMP POWER SUPPLY CABLE. THE LABORATORY'S CIRCUIT BREAKERS DID NOT FUNCTION AS EXPECTED AND ALLOWED POWER TO CONTINUE TO THE 13 AMP CABLE. THE FSE'S INVESTIGATION DETERMINED THAT NONE OF THE ANALYZER/POWER ISSUES WERE DIRECTLY ATTRIBUTED TO ANY ABBOTT PRODUCT. ALL FAULTS WERE CAUSED BY USER ERROR. THE FSE CORRECTED ALL ISSUES AND SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1