BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY CARBON DIOXIDE

    MDR report key: 4133419 · Received October 1, 2014

    Report

    Report Number
    1628664-2014-00215
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 10, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    KHS
    PMA / PMN Number
    K060295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    THE CUSTOMER REPORTED A LOWER THAN EXPECTED CARBON DIOXIDE (CO2) RESULT FOR ONE PATIENT WHILE USING CARBON DIOXIDE REAGENT LN 3L80-21 (LOT 45501UQ01) ON THE ARCHITECT C8000 ANALYZER. THE CUSTOMER REPORTED THAT THE PATIENT SAMPLE IN QUESTION WAS HEMOLYZED AND EXTREMELY LIPEMIC. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS FOR THE ARCHITECT CO2 REAGENT WERE IDENTIFIED. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE CO2 REAGENT PACKAGE INSERT WERE REVIEWED AND WERE FOUND TO ADEQUATELY ADDRESS THE ISSUE. A LITERARY SEARCH FOR ARTICLES SPECIFIC TO THIS ISSUE OF LIPID INTERFERENCE AND LOWER THAN EXPECTED CO2 RESULTS FOUND LIPEMIA TO BE A KNOWN INTERFERANT FOR PHOTOMETRIC ASSAYS AND NOT SPECIFIC TO ABBOTT'S CO2 ASSAY WHICH USES AN ENZYMATIC SPECTROPHOTOMETRIC METHODOLOGY. ALTHOUGH NO SPECIFIC REASON CAN BE IDENTIFIED FOR THIS ISSUE, THE LOWER THAN EXPECTED CO2 RESULTS COULD BE DUE TO EITHER THE INTERFERENCE WITH THE PHOTOMETRIC ANALYSIS BY THE LIGHT SCATTERING EFFECT OF THE LIPIDS OR VOLUME DISPLACEMENT OF THE PLASMA BY THE LIPIDS. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION / DEFICIENCY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A DECREASED CLINICAL CHEMISTRY CO2 RESULT OF <5 MMOL/L WAS GENERATED ON AN EXTREMELY LIPEMIC SAMPLE. THE RESULTS WERE NOT CONSISTENT WITH THE PATIENT HISTORY. A BLOOD GAS WAS ORDERED AND THE CO2 WAS 24 MMOL/L.THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613387 CLINICAL CHEMISTRY CARBON DIOXIDE CARBON DIOXIDE KHS ABBOTT MANUFACTURING INC 45501UQ01

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR SN(B)(4)| ARCHITECT C8000 ANALYZER 1G06-01