BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 2112412 · Received June 3, 2011

    Report

    Report Number
    1628664-2011-00254
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 2, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE. THE FSE AND/OR CUSTOMER REPLACED THE 1ML SYRINGES, CHECK VALVES, INTEGRATED CHIP TECHNOLOGY (ICT) MODULE, AND ICT PROBE. THEN THE FSE REPLACED THE CABLE FROM THE ICT MODULE TO THE PRE AMP BOARD OF THE ANALYZER. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. THERE HAS BEEN NO RECURRENCE OF ERRATIC SODIUM RESULTS SINCE THE CABLE FROM THE ICT MODULE TO THE PRE AMP BOARD WAS REPLACED. 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 (201837-108) CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. BASED ON THE CURRENT EVALUATION AND AVAILABLE INFORMATION, A DEFICIENCY COULD NOT BE IDENTIFIED. REVIEW OF COMPLAINT TRACKING AND TRENDING; FIELD SERVICE INTERVENTION.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE ENGINEER (FSE) AND TECHNICAL SERVICE SPECIALIST (TSS) VISITED THE CUSTOMER SITE. THE FSE PERFORMED EXTENSIVE TROUBLESHOOTING THAT INCLUDED REPLACING MULTIPLE PARTS IN ORDER TO CORRECT THE ISSUE. THE FSE VERIFIED THAT THE CUSTOMER'S WATER SUPPLY WAS ACCEPTABLE FOR USE. THE TSS FOLLOWED UP THE FSE VISIT TO EVALUATE THE CUSTOMER'S SAMPLE HANDLING PROCEDURES. THE TSS CONCLUDED THAT THE CUSTOMER'S CENTRIFUGE IS NOT CAPABLE TO PROVIDE THE ADEQUATE SPIN CHARACTERISTICS REQUIRED BY THE SAMPLE COLLECTION TUBE MANUFACTURER. A CENTRIFUGE WITH A LARGER ROTOR HEAD WOULD ALLOW THE LOWER REVOLUTIONS PER MINUTE TO GENERATE THE NECESSARY RELATIVE CENTRIFUGAL FORCE. THE CUSTOMER HAS EXPERIENCED SOME TUBE BREAKAGE AND AGREED THAT GETTING A REFRIGERATED CENTRIFUGE CAPABLE OF CORRECT SPIN CHARACTERISTICS MAY ULTIMATELY RESOLVE THE ISSUE. THE ARCHITECT SYSTEM OPERATIONS MANUAL (201837-108) CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CONCERN. THE ANALYSER'S SYSTEM LOGS WERE REVIEWED AND INDICATED A POSSIBLE ISSUE WITH SAMPLE HANDLING. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. BASED ON THE AVAILABLE INFORMATION, A PRODUCT DEFICIENCY WAS NOT IDENTIFIED. REVIEW OF COMPLAINT TRACKING AND TRENDING; FIELD SERVICE/TECHNICAL SUPPORT INTERVENTION.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT SAMPLE GENERATED AN INITIAL LOW SODIUM ASSAY RESULT OF 118 MMOL/L ON THE ARCHITECT C16000 ANALYZER. THE SAMPLE RETESTED AT 139 MMOL/L. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED. A SERVICE CALL WAS INITIATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 AERO/C8K ICT MOD LN: 9D28-03| AERO/C8K ICT MOD LN: 9D28-03| AERO/C8K ICT MOD LN: 9D28-03| AERO/C8K ICT MOD LN: 9D28-03