BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C CARBON DIOXIDE REAGENT KIT

    MDR report key: 12795069 · Received November 11, 2021

    Report

    Report Number
    3002809144-2021-00645
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Date of Event
    October 19, 2021
    Report Date
    December 13, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    KHS
    UDI-DI
    00380740121594
    PMA / PMN Number
    K060295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SID (B)(4), SID (B)(4). 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 ALINITY C CARBON DIOXIDE, 07P72-20, ABBOTT GMBH (WIESBADEN) TO ALINITY C PROCESSING MODULE, 03R67-01, IRVING IA/CC. MDR NUMBER 3016438761-2021-00519-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER. H3 OTHER TEXT : AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY C CARBON DIOXIDE, 07P72-20, ABBOTT GMBH (WIESBADEN) TO ALINITY C PROCESSING MODULE, 03R67-01, IRVING IA/CC. MDR NUMBER 3016438761-2021-00519-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C CARBON DIOXIDE (CO2) RESULTS FOR 2 PATIENTS WHILE RUNNING ON THE ALINITY C PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2021, SID 430201: INITIAL RESULTS: CO2 = (B)(6) 2021; REPEAT ON ANOTHER INSTRUMENT: CO2 = (B)(6) 2021. ON (B)(6) 2021, SID 430201: INITIAL RESULTS: CO2 = (B)(6) 2021; REPEAT ON ANOTHER INSTRUMENT: CO2 = (B)(6) 2021. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698061 ALINITY C CARBON DIOXIDE REAGENT KIT ENZYMATIC, CARBON-DIOXIDE KHS ABBOTT GMBH 07P7220 59384UQ03 00380740121594

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY C PROCESSING MODU, 03R67-01, (B)(6).| ALNTY C PROCESSING MODU, 03R67-01, (B)(6).