BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 3252268 · Received July 29, 2013

    Report

    Report Number
    1628664-2013-00186
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 19, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JIH
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER'S ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE CUSTOMER REPLACED THE PROBE TUBING AND THE REAGENT PROBE TO RESOLVE THE ISSUE. TRACKING AND TRENDING DID NOT IDENTIFY ANY ADVERSE TREND FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT C8000 ANALYZER GENERATED A FALSELY ELEVATED LITHIUM RESULT FOR ONE PATIENT SAMPLE. THE ARCHITECT GENERATED AN INITIAL LITHIUM RESULT OF 2.4 AND A REPEAT LITHIUM RESULT OF 0.8 MMOL/L. A SECOND SAMPLE WAS DRAWN FROM THE PATIENT AND LITHIUM RESULTS OF 0.8, 1.5, 1.5, 0.83, 0.88, 0.78, AND 0.80 MMOL/L WERE GENERATED. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352276 ARCHITECT C8000 SYSTEM JIH ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 LN 08L25-30 LOT UNKNOWN| MULTIGENT LITHIUM REAGENT,| LN 08L25-30 LOT UNKNOWN| MULTIGENT LITHIUM REAGENT,