BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C CARBON DIOXIDE REAGENT KIT

    MDR report key: 16449050 · Received February 27, 2023

    Report

    Report Number
    3002809144-2023-00095
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    February 16, 2023
    Report Date
    May 8, 2023
    Manufacturer
    ABBOTT GMBH
    Product Code
    KHS
    UDI-DI
    00380740121594
    PMA / PMN Number
    K060295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER: (B)(6). (2 SEPARATE PATIENTS). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSELY DECREASED ALINITY C CO2 RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY RELATED TRENDS FOR THE PRODUCT FOR THE ISSUE. A TICKET SEARCH BY PRODUCT LOT NUMBER FOUND NORMAL COMPLAINT ACTIVITY. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE REAGENT LOT 62972UQ10 AND CURRENT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. AS PART OF THE TROUBLESHOOTING, IT WAS NOTED THAT THE CUSTOMER HAD ISSUES WITH THE WATER SYSTEM, AND THEY DISCOVERED THEIR WATER WAS NOT BEING CHECKED LAST MONTH. CSC REVIEWED WATER SPECIFICATIONS WITH THE CUSTOMER, THAT IT IS SENSITIVE TO THE CO2 CALIBRATION AND ASSAY PERFORMANCE. QUALITY CONTROL (QC) SHIFTED DOWNWARD AND CAUSED APPROXIMATELY 100 DISCREPANT PATIENT RESULTS. THE QUALITY CONTROL AND PATIENT ISSUE WAS RESOLVED BY REPLACING THE REAGENT LOT. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR ALINITY C CO2 REAGENT LOT 62972UQ10.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY C CO2 RESULTS WHILE RUNNING ON THE ALINITY C PROCESSING MODULE. THE CUSTOMER STATED HAVING ISSUES WITH THE CO2 CALIBRATION GENERATING ERROR MESSAGES THAT LED TO QC ISSUES (SHIFT DOWNWARD), AND CAUSED APPROXIMATELY 100 DISCREPANT PATIENT RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING EXAMPLES OF THE DISCREPANT RESULTS (CUSTOMER¿S NORMAL RANGE: 22-29 MMOL/L) (UNITS OF MEASURE: MMOL/L IS EQUIVALENT TO MEQ/L): (B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY C CO2 RESULTS WHILE RUNNING ON THE ALINITY C PROCESSING MODULE. THE CUSTOMER STATED HAVING ISSUES WITH THE CO2 CALIBRATION GENERATING ERROR MESSAGES THAT LED TO QC ISSUES (SHIFT DOWNWARD), AND CAUSED APPROXIMATELY 100 DISCREPANT PATIENT RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING EXAMPLES OF THE DISCREPANT RESULTS (CUSTOMER¿S NORMAL RANGE: 22-29 MMOL/L) (UNITS OF MEASURE: MMOL/L IS EQUIVALENT TO MEQ/L): (B)(6), (B)(6) 2023 22:10:31.327 CO2 RESULT: 18 MMOL/L. (B)(6), (B)(6) 2023 22:48:55.700 CO2 RESULT: 24 MMOL/L. (B)(6), (B)(6) 2023 22:11:35.363 CO2 RESULT: 17 MMOL/L (B)(6), (B)(6) 2023 23:46:12.427 CO2 RESULT: 23 MMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559871 ALINITY C CARBON DIOXIDE REAGENT KIT ENZYMATIC, CARBON-DIOXIDE KHS ABBOTT GMBH 07P7220 62972UQ10 00380740121594

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY C PROCESSING MODU, 03R67-01, AC05041| ALNTY C PROCESSING MODU, 03R67-01, AC05041