BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 5746884 · Received June 23, 2016

    Report

    Report Number
    1628664-2016-00178
    Event Type
    Malfunction
    Date Received
    June 23, 2016
    Date of Event
    May 27, 2016
    Report Date
    August 25, 2016
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    A BLUE LIGHT DISCHARGE (SPARK) FROM THE SYSTEM CONTROL CENTER (SCC) POWER STRIP OUTLET WAS OBSERVED AS THE CUSTOMER PULLED THE CENTRAL PROCESSING UNIT (CPU) OUT TO TROUBLESHOOT THE SCC MONITOR THAT PREVIOUSLY WENT BLANK. NO FLAME WAS SEEN, NO SMOKE WAS SEEN, NO ODOR OF SMOKE WAS OBSERVED, AND NO INJURIES WERE REPORTED. AN ABBOTT FIELD SERVICE ENGINEER WAS DISPATCHED TO THE ACCOUNT AND DID NOT FIND VISUAL DAMAGE TO EITHER THE EXTERIOR OR THE INTERNAL COMPONENTS OF THE POWER SUPPLY, HOWEVER THE CPU WOULD NOT POWER UP. PARTS INVOLVED INCLUDED SCC-F + POWER SUPPLY (ROHS) (PART NUMBER 7-206072-01) AND SCC POWER STRIP OUTLET (PART NUMBER 100610-101). THE SCC WAS DISCONNECTED FROM THE SCC POWER STRIP OUTLET AND THE SCC WAS CONNECTED DIRECTLY TO THE UNINTERRUPTIBLE POWER SUPPLY (UPS). INSPECTION OF THE INTERNAL WIRING OF THE SCC POWER STRIP OUTLET FOUND NO EVIDENCE OF BURN DAMAGE. THE SCC POWER STRIP OUTLET WAS REPLACED BECAUSE IT DID NOT WORK, HOWEVER NO DAMAGE WAS IDENTIFIED TO EITHER THE SCC-F + POWER SUPPLY (ROHS) (PART NUMBER 7-206072-01) OR THE SCC POWER STRIP OUTLET (PART NUMBER 100610-101). ONCE THE PARTS WERE REPLACED THE ANALYZER WAS ABLE TO POWER UP. THE ANALYZER WAS RETURNED TO NORMAL OPERATION. INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. NO SUBSEQUENT REPORTS OF SPARKING, SMOKE, OR BURN ISSUES WERE IDENTIFIED. HISTORICAL COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TREND WAS IDENTIFIED. PRODUCT LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE ISSUE WAS RESOLVED THROUGH NORMAL TROUBLESHOOTING PROCEDURES. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS COMPLAINT INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A BLUE SPARK FROM THE POWER STRIP ATTACHED TO THE ARCHITECT I2000SR ANALYZER CENTRAL PROCESSING UNIT (CPU). THE CUSTOMER STATED THE MONITOR WENT BLACK, AND THE CUSTOMER PERFORMED A HARD SHUTDOWN OF THE CPU. WHEN THE CPU WAS POWERED OFF, THE CUSTOMER WENT TO THE BACK OF THE ANALYZER TO CHECK THE CABLE CONNECTIONS. AS THE CUSTOMER PULLED THE CPU OUT TO CHECK CONNECTIONS, THEY OBSERVED A BLUE SPARK FROM THE POWER STRIP ATTACHED TO THE BACK OF THE CPU. NO ONE WAS SHOCKED BY THE SPARK. THE ANALYZER WAS POWERED OFF AND THE CPU WAS SHUT DOWN. NO FLAME AND NO SMOKE WERE OBSERVED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398493 ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1