BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBON DIOXIDE

    MDR report key: 11837851 · Received May 17, 2021

    Report

    Report Number
    3002809144-2021-00319
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    May 7, 2021
    Report Date
    July 6, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    KHS
    UDI-DI
    00380740161521
    PMA / PMN Number
    K060295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE FOR THE CARBON DIOXIDE (LN 03L80-22) LOT UNKNOWN. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF CARBON DIOXIDE (LN 03L80-22) LOT UNKNOWN WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER WAS TRUNCATED; FULL SID IS (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER GENERATED FALSELY ELEVATED CARBON DIOXIDE RESULTS FOR ONE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED: SID (B)(6): CO2 INITIAL RESULT 37 MMOL/L, REPEATED 30 MMOL/L, REPEATED WITH ANOTHER METHOD (ISTAT) 28 MMOL/L THE CUSTOMER BELIEVES THE ALTERNATE METHOD (ISTAT) GENERATED THE CORRECT RESULT FOR ALL ANALYTES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732416 CARBON DIOXIDE ENZYMATIC, CARBON-DIOXIDE KHS ABBOTT GMBH 3L80-22 00380740161521

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC C4000 INTGR, 02P24-40, C402335