BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBON DIOXIDE

    MDR report key: 11895206 · Received May 27, 2021

    Report

    Report Number
    3002809144-2021-00339
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    May 21, 2021
    Report Date
    June 28, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELLING REVIEW, AND DEVICE HISTORY RECORD REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TICKETS DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR THE COMPLAINT LOT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT LOT AND THE COMPLAINT ISSUE. LABELING IS ADEQUATE AND PROVIDES SPECIFIC INSTRUCTIONS TO THE CUSTOMER REGARDING THE CURRENT ISSUE. THE CUSTOMER RECALIBRATED THE SAME REAGENT (NEW KIT), HOWEVER GOT THE SAME CALIBRATION PROFILE AND CONTROL VALUES ON BOTH MODULES. MAINTENANCE AND TROUBLESHOOTING WAS PERFORMED. THE ISSUE APPEARS TO BE SAMPLE SPECIFIC FOR CERTAIN PATIENT SAMPLES AND/OR HANDLING OF CALIBRATOR. QUALITY CONTROLS REMAIN WITHIN RANGE AT THE TIME OF THE INCIDENT. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.SECTION D10. CONCOMITANT PRODUCT- ADDITIONAL PRODUCT ADDED CC CO2 CAL(6X5ML), 01E64-03, 98513FD01 MANUFACTURE DATE 12/23/2020, AND EXPIRATION DATE 12/15/2021.

    Additional Manufacturer Narrative · 1

    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 OBSERVED A SHIFT DOWN IN CO2 (CARBON DIOXIDE) RESULTS GENERATED ON THE ARCHITECT C4000 INSTRUMENT AFTER CHANGING THE CALIBRATOR LOT WHEN COMPARED TO THE BLOOD GAS CO2 RESULTS. PATIENT 1 ARCHITECT CO2 RESULT WAS 19 MMOL/L, BLOOD GAS RESULT WAS 28.7 MMOL/L, (REFERENCE RANGE 22 MMOL/L TO 29 MMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790615 CARBON DIOXIDE ENZYMATIC, CARBON-DIOXIDE KHS ABBOTT GMBH 3L80-22 58158UQ10 00380740161521

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC C4000 INTGR, 02P24-40, C401506| ARC C4000 INTGR, 02P24-40, C401506| CC CO2 CAL(6X5ML), 01E64-03, 98513FD01