BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBON DIOXIDE

    MDR report key: 11807359 · Received May 11, 2021

    Report

    Report Number
    3002809144-2021-00308
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 22, 2021
    Report Date
    May 18, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    KHS
    UDI-DI
    00380740161521
    PMA / PMN Number
    K060295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP IS SUBMITTED TO POPULATE FIELDS D8 AND/OR H6 WITH DATA THAT HAD PREVIOUSLY BEEN PROVIDED IN FIELD H10. THERE IS NO CHANGE TO THE CONTENT OF THE DATA.

    Additional Manufacturer Narrative · 1

    (B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. PATIENT INFORMATION: NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. TRENDING REVIEW IDENTIFIED NO TRENDS RELATED TO FALSELY ELEVATED PATIENT RESULTS FOR THE ARCHITECT CARBON DIOXIDE ASSAY. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. REVIEW OF THE COMPLAINT TEXT AND INFORMATION PROVIDED BY THE CUSTOMER FOUND THAT RETESTING OF THE SAMPLES AFTER RECALIBRATING GENERATED THE EXPECTED RESULTS. DEVICE HISTORY RECORD REVIEW FOR THE ASSAY DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS RELATED TO THE COMPLAINT ISSUE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CARBON DIOXIDE (CO2) ASSAY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED FALSELY ELEVATED ARCHITECT CARBON DIOXIDE RESULTS FROM MULTIPLE SAMPLES. THE CUSTOMER PROVIDED AN EXAMPLE OF A SAMPLE THAT GENERATED AN INITIAL RESULT OF 36 MMOL/L AND REPEAT FOLLOWING RECALIBRATION GENERATED 26 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704873 CARBON DIOXIDE ENZYMATIC, CARBON-DIOXIDE KHS ABBOTT GMBH 3L80-22 00380740161521

    Patients

    Seq Age Sex Outcome Treatment
    1