BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBON DIOXIDE

    MDR report key: 12816709 · Received November 15, 2021

    Report

    Report Number
    3002809144-2021-00649
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Date of Event
    October 29, 2021
    Report Date
    December 13, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    KHS
    UDI-DI
    00380740161521
    PMA / PMN Number
    K060295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PATIENT DEMOGRAPHIC INFORMATION WAS PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM CARBON DIOXIDE, LIST NUMBER 03L80-22, MANUFACTURED BY ABBOTT GMBH IN WIESBADEN TO ARCHITECT C4000, LIST NUMBER 02P24-40, MANUFACTURED BY ABBOTT LABS IN IRVING. MDR NUMBER 3016438761-2021-00517 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER QUESTIONED CARBON DIOXIDE RESULTS FOR MULTIPLE PATIENTS. THE CUSTOMER USES THE REFERENCE RANGE 22-29 MMOL/L. THE FOLLOWING INFORMATION WAS PROVIDED: SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. SID "(B)(4)" INITIAL RESULT (B)(6) MMOL/L REPEATED RESULT (B)(6) MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1708669 CARBON DIOXIDE ENZYMATIC, CARBON-DIOXIDE KHS ABBOTT GMBH 3L80-22 59776UQ05 00380740161521

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC C4000 INTGR, 02P24-40, (B)(6) | ARC C4000 INTGR, 02P24-40, (B)(6).