BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 2022899 · Received March 18, 2011

    Report

    Report Number
    1628664-2011-00118
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    January 13, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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). FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A REVIEW OF INSTRUMENT LOGS, INTERNAL TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE CUSTOMER MOVED THE LITHIUM ASSAY TO THE OPPOSITE LINE ON THE (B)(4) TO AVOID CARRYOVER FROM THE LDH ASSAY, AND NO FURTHER LITHIUM FLYERS WERE OBSERVED. A REVIEW OF THE SYSTEM LOGS CONFIRMED THE CUSTOMER'S COMPLAINT, AND THAT THEY R1 REAGENT PROBE HAD DISPENSED LDH REAGENT IMMEDIATELY PRIOR TO DISPENSING LITHIUM REAGENT. AN INTERNAL CARRYOVER STUDY WAS PERFORMED FOR LITHIUM AND LDH REAGENTS ON TWO DIFFERENT ARCHITECT SYSTEMS, AND LDH CARRYOVER TO THE LITHIUM ASSAY WAS NOT PRESENT ON EITHER SYSTEM. TRACKING AND TRENDING IDENTIFIED NO ADVERSE TRENDS FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE CUSTOMER WAS POINTED TO PRODUCT INFORMATION LETTER (B)(6) WHICH ADDRESSES CARRYOVER ISSUES. BASED ON THE INFORMATION PROVIDED, AND THE RESULTS OF THE INTERNAL STUDY, NO DEFICIENCY CAN BE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THEY HAVE NOTICED FALSELY ELEVATED RESULTS WHEN PROCESSING PATIENT SAMPLES USING THE ARCHITECT C16000 WITH THE LITHIUM ASSAY. A PATIENT SAMPLE GENERATED A LITHIUM VALUE OF 2.610 MMOL/L COMPARED TO A REPEAT RESULT OF 0.004 MMOL/L. NO ADVERSE OUTCOMES WERE REPORTED RELATED TO THIS ISSUE.

    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 ARC MULTIGENT LITHIUM LN 8L25-01 LOT # 00215Y600| ARC MULTIGENT LITHIUM LN 8L25-01 LOT # 00215Y600