BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 1841340 · Received September 22, 2010

    Report

    Report Number
    1628664-2010-00335
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Report Date
    September 19, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4), FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE ABBOTT FIELD SERVICE (FSR) FOUND A GEL-LIKE BUILDUP IN THE ICT REFERENCE (IREF) SOLUTION CUP. THE FSR CLEANED THE IREF CUP AND PROBES, FLUSHED THE ICT LINES AND MODULE WITH SODIUM HYPOCHLORITE AND DI WATER, VERIFIED TUBING AND SYRINGES WERE OK, AND VERIFIED PERFORMANCE OF THE ICT MODULE WITH CALIBRATION AND QUALITY CONTROLS. FOLLOW-UP WITH THE CUSTOMER 10 DAYS LATER CONFIRMED NO FURTHER OCCURRENCE OF INCONSISTENT POTASSIUM RESULTS WERE NOTED. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND LINKED TO DIRTY/CONTAMINATED IREF CUPS CAUSING DISCREPANT ICT RESULTS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION,, THE IDENTIFIED THE PROBABLE CAUSE TO BE THE GEL-LIKE BUILDUP IN THE IREF CUP, AND CLEANING THE IREF CUP, PROBES, ICT MODULE AND ICT LINES RESOLVED THE ISSUE. THE EVALUATION DID NOT IDENTIFY A DEFICIENCY OF THE ICT REFERENCE SOLUTION CUP OR THE C16000 SYSTEM.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT C16000 ANALYZER GENERATED A FALSELY ELEVATED POTASSIUM RESULT FOR ONE PATIENT SAMPLE. THE ANALYZER GENERATED AN INITIAL POTASSIUM RESULT OF 6.1 AND A REPEAT POTASSIUM RESULT OF 4.3. THE FALSELY ELEVATED POTASSIUM RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    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