BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1879039 · Received October 21, 2010

    Report

    Report Number
    1628664-2010-00386
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 8, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    NDW
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN RESPONSE TO THIS ISSUE AN INVESTIGATION WAS INITIATED TO FURTHER EXAMINE THE CUSTOMER'S OBSERVATION. THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND A REVIEW OF THE SERVICE HISTORY FOR THE ANALYZER IN QUESTION. A REVIEW OF THE ARCHITECT RESULTS LOG WAS COMPLETED AND DID NOT IDENTIFY ANY ISSUES. THERE WERE NO LIQUID LEVEL SENSE LOGS AVAILABLE. THE SAMPLES REPORTED BY THE CUSTOMER TO THE PHYSICIANS FOR THE EXTREMELY HIGH LITHIUM LEVELS WERE PRESENT IN THE LOG. IN ADDITION, THE CALIBRATION OF THE LITHIUM ASSAY AND THE CONTROLS THAT WERE RUN ALONG WITH THE CALIBRATION WERE REVIEWED. THERE WAS NO REPEAT TESTING OF THE ELEVATED SAMPLES AT THE TIME THE HIGH RESULTS WERE GENERATED. THE TEXT OF THE COMPLAINT NOTES THAT PHYSICIANS QUESTIONED THE RESULTS AND ORDERED ADDITIONAL SAMPLES. THE REPEAT-TESTING SAMPLE ID NUMBERS WERE NOT AVAILABLE, HOWEVER THE REPEAT TESTING OF THE ORIGINAL SAMPLES WAS TRACED AND THE LOWER RESULTS WERE CONFIRMED. THE CUSTOMER INSTITUTED A NEW LABORATORY PRACTICE OF REPEAT ALL ELEVATED LITHIUM RESULTS. PRODUCT LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS PROBABLE CAUSES AND CORRECTIONS FOR ERRATIC RESULTS. BASED ON THE AVAILABLE DATA, WE CANNOT DETERMINE THE EXACT CAUSE OF THE DISCREPANT RESULTS YOU SAW. HOWEVER, THE MOST LIKELY CAUSE IS SOME FIBRIN OR PARTICULATES IN THE SAMPLE OR SMALL BUBBLES ON THE REAGENT SURFACE. EITHER OPTION CAN GENERATE THE SCENARIO THE CUSTOMER OBSERVED. THE CUSTOMER WAS INFORMED THAT THE ARCHITECT SOFTWARE HAS THE CAPABILITY OF FLAGGING RESULTS THAT ARE CONSIDER ELEVATED ENOUGH TO REQUIRE AN IMMEDIATE ALERT TO THE OPERATOR. THESE OPTIONAL PARAMETERS WERE NOT PRESENT IN THE CUSTOMER'S LITHIUM ASSAY CONFIGURATION. BASED UPON THE INVESTIGATION, IT HAS BEEN DETERMINED THAT THE ARCHITECT C8000 ANALYZER, LIST NUMBER 1G06-01, (B)(4), IS PERFORMING AS INTENDED. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED FALSELY ELEVATED LITHIUM RESULTS HAD OCCURRED ON THE ARCHITECT C8000 FOR TWO PATIENT SAMPLES. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND LATER DETECTED WHEN THE PHYSICIANS SENT REPEAT SAMPLES TO THE LABORATORY. PATIENT TWO OF TWO GENERATED AN INITIAL LITHIUM RESULT OF 2.540 MMOL/L WITH A REPEAT RESULT OF 0.5 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER NDW ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 LITHIUM, LIST# 8L25-01, LOT# 00215Y600| LITHIUM, LIST# 8L25-01, LOT# 00215Y600