BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1913080 · Received December 2, 2010

    Report

    Report Number
    1628664-2010-00450
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JGS
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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

    (B)(4). AN ABBOTT FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND FOUND THE INTEGRATED CHIP TECHNOLOGY (ICT) PROBE WAS BENT. THE ICT PROBE WAS REPLACED AND THE ICT MODULE WAS ALIGNED. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. COMPLAINT ACTIVITY WAS REVIEWED AND IDENTIFIED NO ADVERSE TRENDS IN ASSOCIATION WITH THE ISSUE CURRENTLY UNDER EVALUATION. THE ICT SAMPLE DILUENT PACKAGE INSERT ((B)(4)) AND THE ARCHITECT SYSTEMS OPERATIONS MANUAL ((B)(4)) CONTAIN INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE (THE OPERATIONS MANUAL DOES NOT PROVIDE ICT PROBE ALIGNMENT PROCEDURES FOR CUSTOMER USE). BASED ON THE AVAILABLE INFORMATION, A BENT ICT PROBE IS THE MOST LIKELY CAUSE FOR THE DISCREPANT RESULTS. CUSTOMER AND FIELD SERVICE ACTIONS TAKEN TO RESOLVE THE ISSUE ARE CONSISTENT WITH TROUBLESHOOTING INFORMATION PROVIDED IN THE ARCHITECT OPERATIONS MANUAL. REVIEW OF COMPLAINT TRACKING AND TRENDING; CUSTOMER AND FIELD SERVICE INTERVENTION.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT PATIENT RESULTS WERE REPORTED OUT AS "CRITICAL" FOR ELECTROLYTES TESTED ON THE ARCHITECT C8000 ANALYZER AND WHEN RETESTED ON A BACK-UP ARCHITECT C8000 ANALYZER (SN (B)(4)), RESULTS WERE WITHIN THE LAB'S NORMAL REFERENCE RANGES. THE CUSTOMER PROVIDED THE FOLLOWING: INITIAL: SODIUM <100, 103L; RETEST: 141 MMOL/L; POTASSIUM 3.3, 3.9 MMOL/L; CHLORIDE 91, 106 MMOL/L; THE CUSTOMER USES THE FOLLOWING NORMAL REFERENCES RANGES: SODIUM 136 TO 145 MMOL/L; POTASSIUM 3.5 TO 5.1 MMOL/L; CHLORIDE 98 TO 110 MMOL/L; CONTROLS HAVE REMAINED WITHIN SPECIFICATIONS. THE CUSTOMER WOULD PROVIDE NO PATIENT INFORMATION. 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 C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JGS ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 AERO C8K ICT MOD LN: 9D28-03 LOT: 100917| AERO C8K ICT MOD LN: 9D28-03 LOT: 100917