BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBON DIOXIDE

    MDR report key: 13059687 · Received December 22, 2021

    Report

    Report Number
    3002809144-2021-00712
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    December 14, 2021
    Report Date
    January 24, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    KHS
    UDI-DI
    00380740161521
    PMA / PMN Number
    K060295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED CARBON DIOXIDE RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. THE LOT SEARCH DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE CURRENT COMPLAINT ISSUE. TRENDING WAS REVIEWED AND DID NOT IDENTIFY ANY TRENDS FOR THE PRODUCT FOR THE ISSUE. FILE SAMPLE ANALYSIS WAS NOT PERFORMED. AS PART OF TROUBLESHOOTING, THE PATIENT SAMPLES WERE TESTED ON A DIFFERENT SYSTEM AND GAVE LOWER RESULTS. QUALITY CONTROL (QC) MATERIAL THAT INITIALLY GENERATED ELEVATED RESULTS IS NOW GENERATING ACCEPTABLE RESULTS AND THE COMPLAINT ISSUE WAS REPORTED TO BE RESOLVED. THE DEVICE HISTORY RECORDED WAS REVIEWED AND DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY FOR CARBON DIOXIDE REAGENT LOT 60106UQ07 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER: SID (B)(6) (2 PATIENTS). ALL AVAILABLE PATIENT INFORMATION IS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED CARBON DIOXIDE (CO2) RESULTS FOR 2 PATIENTS WHILE RUNNING ON THE ARCHITECT C8000 PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2021 SID (B)(6): INITIAL CO2 RESULT: 30.9 MEQ/L, REPEAT ON ANOTHER ANALYZER: 23.7 MEQ/L. ON (B)(6) 2021 SID (B)(6): INITIAL CO2 RESULT: 31.4 MEQ/L, REPEAT ON ANOTHER ANALYZER: 25.8 MEQ/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965165 CARBON DIOXIDE ENZYMATIC, CARBON-DIOXIDE KHS ABBOTT GMBH 3L80-22 60106UQ07 00380740161521

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC C8 PROC MOD, 01G06-11, C803309| ARC C8 PROC MOD, 01G06-11, C803309