BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBON DIOXIDE

    MDR report key: 11784562 · Received May 6, 2021

    Report

    Report Number
    3002809144-2021-00295
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 12, 2021
    Report Date
    May 28, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    KHS
    UDI-DI
    00380740161521
    PMA / PMN Number
    K060295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF TICKETS DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR ARCHITECT CARBON DIOXIDE (CO2) LOT 58158UQ10. TRENDING REVIEW FOR THE ASSAY IDENTIFIED NO TRENDS FOR FALSELY DEPRESSED PATIENT RESULTS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. RETESTING OF THE SAMPLES AFTER RECALIBRATING GAVE EXPECTED RESULTS. 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) LOT 58158UQ10 WAS IDENTIFIED.THIS FOLLOW UP IS BEING SUBMITTED TO INCLUDE D8 AND H6 INFORMATION PREVIOUSLY SUBMITTED USING THE H10 SECTION IN THEIR RESPECTIVE FIELDS.

    Additional Manufacturer Narrative · 1

    (B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT IDENTIFIER: MULTIPLE = (B)(6). PATIENT INFORMATION: NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED FALSELY DEPRESSED ARCHITECT CARBON DIOXIDE RESULTS FOR MULTIPLE SAMPLES. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL RESULTS WERE GENERATED WITH THE PREVIOUS LOT AND REPEAT RESULTS WERE GENERATED WITH THE NEW LOT FOLLOWING CALIBRATION. PATIENT 1: 19 AND 22 MMOL/L. PATIENT 2: 20 AND 23 MMOL/L. PATIENT 3: 19 AND 23 MMOL/L. PATIENT 4: 20 AND 24 MMOL/L. ADDITIONAL DISCREPANT RESULTS WERE PROVIDED WITH THE INITIAL RESULT ON THE PREVIOUS LOT, REPEAT ON THE NEW LOT AND SECOND REPEAT ON THE NEW LOT FOLLOWING CUVETTE WASH AND RECALIBRATION. SAMPLE ID (B)(6) : 19, 22 AND 24 MMOL/L. SAMPLE ID (B)(6): 19, 22 AND 24 MMOL/L. SAMPLE ID (B)(6): 19, 21 AND 24 MMOL/L. SAMPLE ID (B)(6): 17, 20 AND 22 MMOL/L. SAMPLE ID (B)(6): 19, 21 AND 23 MMOL/L. SAMPLE ID (B)(6): 19, 22 AND 24 MMOL/L. SAMPLE ID (B)(6): 19, 22 AND 24 MMOL/L. SAMPLE ID (B)(6): 19, 21 AND 24 MMOL/L. SAMPLE ID (B)(6): 17, 20 AND 22 MMOL/L. SAMPLE ID (B)(6): 19, 21 AND 23 MMOL/L. SAMPLE ID (B)(6): 20, 23 AND 26 MMOL/L. SAMPLE ID (B)(6): 21 AND 24 MMOL/L. SAMPLE ID (B)(6): 20 AND 23 MMOL/L. SAMPLE ID (B)(6): 20 AND 24 MMOL/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683486 CARBON DIOXIDE ENZYMATIC, CARBON-DIOXIDE KHS ABBOTT GMBH 3L80-22 58158UQ10 00380740161521

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC C4000 INTGR, 02P24-40, (B)(4)| ARC C4000 INTGR, 02P24-40, (B)(4)