BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBON DIOXIDE

    MDR report key: 11952066 · Received June 7, 2021

    Report

    Report Number
    3002809144-2021-00356
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 13, 2021
    Report Date
    June 7, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    KHS
    UDI-DI
    00380740161521
    PMA / PMN Number
    K060295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF TICKETS DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR LOT 58505UQ11. TRENDING REVIEW DETERMINED NO TREND IDENTIFIED FOR FALSELY DEPRESSED RESULTS FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. MAINTENANCE OF THE NON-ABBOTT WATER QUALITY SYSTEM AND RE-ESTABLISHING THE REQUIRED PRODUCT WATER QUALITY TO THE INSTRUMENT CORRECTED THE RESULTS ISSUE. RESULTS WERE RETURNED TO EXPECTED LEVELS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. THE DEVICE HISTORY RECORD REVIEW IDENTIFIED NO NON-CONFORMANCES OR DEVIATIONS RELATED TO THE COMPLAINT ISSUE. A REVIEW OF THE LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CARBON DIOXIDE REAGENT, LOT NUMBER 58505UQ11 WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A HIGH ANION GAP FOR A PATIENT WHILE USING THE ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE ANION GAP: 11-16): SODIUM = CURRENT = 133 MMOL/L / PREVIOUS = 143 MMOL/L. POTASSIUM = CURRENT = 4.6 MMOL/L / PREVIOUS = 5.1 MMOL/L. CHLORIDE = CURRENT = 107 MMOL/L / PREVIOUS = 113 MMOL/L. BICARBONATE (CO2) = CURRENT = 17 MMOL/L / PREVIOUS = 23 MMOL/L. ANION GAP = CURRENT = 18 / PREVIOUS = 12. THE ANION GAP IS CALCULATED MEASUREMENT FROM SODIUM, CHLORIDE AND BICARBONATE (CO2). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849085 CARBON DIOXIDE ENZYMATIC, CARBON-DIOXIDE KHS ABBOTT GMBH 3L80-22 58505UQ11 00380740161521

    Patients

    Seq Age Sex Outcome Treatment
    1