BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C CARBON DIOXIDE REAGENT KIT

    MDR report key: 23076319 · Received September 17, 2025

    Report

    Report Number
    3002809144-2025-00296
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    August 19, 2025
    Report Date
    November 5, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    KHS
    UDI-DI
    00380740121594
    PMA / PMN Number
    K060295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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, DEVICE HISTORY RECORD REVIEW, FIELD DATA REVIEW AND LABELING REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY C CARBON DIOXIDE ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 67723UQ01. THE DEVICE HISTORY RECORD REVIEW FOUND NO ISSUE RELATED TO THE CURRENT COMPLAINT FOR LOT NUMBER 67723UQ01. THE OVERALL PERFORMANCE OF THE ALINITY C CARBON DIOXIDE REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR THE LOT NUMBERS IN THE FIELD FOR LOT NUMBER 67723UQ01 IS WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT PERFORMANCE WAS IDENTIFIED. REVIEW OF LABELING FOUND ADEQUATE INFORMATION REGARDING THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C CARBON DIOXIDE REAGENT LOT 67723UQ01 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR SECTION A1 PATIENT IDENTIFIER: SID (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DEPRESSED ALINITY C CARBON DIOXIDE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 22 ¿ 32 MMOL/L): ON (B)(6) 2025, SID (B)(6), INITIAL CO2 RESULT(B)(6) = 6.8 MMOL/L; REPEAT RESULT= 6.8 MMOL/L; REPEAT RESULT (B)(6) = 4.1 MMOL/L; RADIOMETER CO2 RESULT= 20 MMOL/L (RELEASED RESULT); LIPEMIA INDEX= 1.3; TRIGLYCERIDE= 27 MMOL/L. ADDITIONAL RESULTS WERE PROVIDED: QEP (SERUM PROTEIN ELECTROPHORESIS) AND SFLC (SERUM FREE LIGHT CHAIN) WERE NORMAL. ADDITIONAL SAMPLES WERE COLLECTED WITH THE FOLLOWING RESULTS: SID (B)(6) , INITIAL CO2 RESULT= 15 MMOL/L; RADIOMETER CO2= 17 MMOL/L, LIPEMIA INDEX= 0.83, TRIGLYCERIDES= 21.9. ON (B)(6) 2025, SID (B)(6) , INITIAL CO2 RESULT= 21 MMOL/L; RADIOMETER CO2 RESULT = 25 MMOL/L; LIPEMIA INDEX= 0.29. ON (B)(6) 2025, SID (B)(6), INITIAL CO2 RESULT= 21 MMOL/L; RADIOMETER CO2 RESULT = 23 MMOL/L; LIPEMIA INDEX= 0.11; TRIGLYCERIDES= 4.9. ON (B)(6) 2025, SID (B)(6), INITIAL CO2 RESULT= 23 MMOL/L; RADIOMETER CO2 RESULT = 25 MMOL/L; LIPEMIA INDEX= 0.38; TRIGLYCERIDES= 5.8 THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DEPRESSED ALINITY C CARBON DIOXIDE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 22 ¿ 32 MMOL/L): (B)(6) 2025, SID (B)(6), INITIAL CO2 RESULT ((B)(6)) = 6.8 MMOL/L; REPEAT RESULT= 6.8 MMOL/L; REPEAT RESULT ((B)(6)) = 4.1 MMOL/L; RADIOMETER CO2 RESULT= 20 MMOL/L (RELEASED RESULT); LIPEMIA INDEX= 1.3; TRIGLYCERIDE= 27 MMOL/L ADDITIONAL RESULTS WERE PROVIDED: QEP (SERUM PROTEIN ELECTROPHORESIS) AND SFLC (SERUM FREE LIGHT CHAIN) WERE NORMAL. ADDITIONAL SAMPLES WERE COLLECTED WITH THE FOLLOWING RESULTS: SID (B)(6), INITIAL CO2 RESULT= 15 MMOL/L; RADIOMETER CO2= 17 MMOL/L, LIPEMIA INDEX= 0.83, TRIGLYCERIDES= 21.9. (B)(6) 2025, SID (B)(6), INITIAL CO2 RESULT= 21 MMOL/L; RADIOMETER CO2 RESULT = 25 MMOL/L; LIPEMIA INDEX= 0.29. (B)(6) 2025, SID (B)(6), INITIAL CO2 RESULT= 21 MMOL/L; RADIOMETER CO2 RESULT = 23 MMOL/L; LIPEMIA INDEX= 0.11; TRIGLYCERIDES= 4.9. (B)(6) 2025, SID (B)(6), INITIAL CO2 RESULT= 23 MMOL/L; RADIOMETER CO2 RESULT = 25 MMOL/L; LIPEMIA INDEX= 0.38; TRIGLYCERIDES= 5.8 THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111464 ALINITY C CARBON DIOXIDE REAGENT KIT ENZYMATIC, CARBON-DIOXIDE KHS ABBOTT GMBH 67723UQ01 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).