BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 21838917 · Received April 15, 2025

    Report

    Report Number
    3016438761-2025-00224
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    March 24, 2025
    Report Date
    May 8, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    K170316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTION B5 DESCRIBE EVENT OR PROBLEM: CHANGED CORRECT VERBIAGE TO: THE CUSTOMER OBSERVED DISCREPANT CARBON DIOXIDE (CO2) RESULTS GENERATED FROM ALINITY C PROCESSING MODULE FOR MULTIPLE PATIENTS. FROM INCORRECT VERBIAGE: THE CUSTOMER OBSERVED DISCREPANT CHLORIDE RESULTS GENERATED FROM ALINITY C PROCESSING MODULE FOR MULTIPLE PATIENTS.

    Additional Manufacturer Narrative · 0

    DURING THE REQUESTED SITE VISIT, THE FIELD SERVICE ENGINEER (FSE) PERFORMED MULTIPLE TROUBLESHOOTING PROCEDURES BUT WAS UNABLE TO DETERMINE A SINGLE DEFINITIVE LIKELY CAUSE PART AND THE ALINITY I PROCESSING MODULE, SERIAL NUMBER (B)(6) WAS CONSIDERED THE LIKELY CAUSE OF THE RESULT ISSUES. THERE WERE NO ADDITIONAL SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF TRACKING AND TRENDING OF THE ALINITY I PROCESSING MODULE DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. THE ALINITY CI-SERIES OPERATIONS MANUAL PROVIDES ADEQUATE INFORMATION REGARDING THE TROUBLESHOOTING OF ERRATIC/DISCREPANT RESULTS. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR ALINITY I PROCESSING MODULE, SERIAL NUMBER (B)(6).

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DISCREPANT CARBON DIOXIDE (CO2) RESULTS GENERATED FROM ALINITY C PROCESSING MODULE FOR MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2025 PATIENT 3: INITIAL= 22 MEQ/L /REPEATED=21 MEQ/L. PATIENT 5: INITIAL=21 MEQ/L /REPEATED=22 MEQ/L. LABORATORY REFERENCE RANGE FOR CO2=22 TO 29 MEQ/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DISCREPANT CARBON DIOXIDE (CO2) RESULTS GENERATED FROM ALINITY C PROCESSING MODULE FOR MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2025 PATIENT 3: INITIAL= 22 MEQ/L /REPEATED=21 MEQ/L. PATIENT 5: INITIAL=21 MEQ/L /REPEATED=22 MEQ/L. LABORATORY REFERENCE RANGE FOR CO2=22 TO 29 MEQ/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DISCREPANT CHLORIDE RESULTS GENERATED FROM ALINITY C PROCESSING MODULE FOR MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2025 PATIENT 3: INITIAL= 22 MEQ/L /REPEATED=21 MEQ/L. PATIENT 5: INITIAL=21 MEQ/L /REPEATED=22 MEQ/L. LABORATORY REFERENCE RANGE FOR CO2=22 TO 29 MEQ/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121944 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown