BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C CARBON DIOXIDE REAGENT KIT

    MDR report key: 20905294 · Received December 11, 2024

    Report

    Report Number
    3002809144-2024-00352
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    November 16, 2024
    Report Date
    January 13, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    KHS
    UDI-DI
    00380740121594
    PMA / PMN Number
    K060295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A1 - PATIENT IDENTIFIER COMPLETE ENTRY = (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY C CARBON DIOXIDE REAGENT, LIST NUMBER 07P72-20, AND MANUFACTURING SITE OF WIESBADEN TO ALINITY C PROCESSING MODULE, LIST NUMBER 03R67-01, AND MANUFACTURING SITE OF IRVING. MDR NUMBER 3016438761-2025-00024-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY C CARBON DIOXIDE RESULTS FOR SEVERAL PATIENTS. THE FOLLOWING EXAMPLE WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 22-31 MMOL/L): SAMPLE ID (B)(6) RESULT WAS 8 MMOL/L, NO REPEAT RESULTS WERE AVAILABLE. THE PATIENT¿S PREVIOUS RESULT WAS 24 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813859 ALINITY C CARBON DIOXIDE REAGENT KIT ENZYMATIC, CARBON-DIOXIDE KHS ABBOTT GMBH 66642UQ07 00380740121594

    Patients

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