BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 22938328 · Received September 2, 2025

    Report

    Report Number
    3016438761-2025-00502
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 19, 2025
    Report Date
    September 25, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    PMA / PMN Number
    K170316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER INSPECTED THE INSTRUMENT; HOWEVER, A SINGLE DEFINITIVE PART COULD NOT BE DETERMINED AS THE LIKELY CAUSE. THE INSTRUMENT SERVICE HISTORY REVIEW FOR AC04188 REVEALED NO ADDITIONAL SERVICE TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC RESULTS. 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 FOR THE ALINITY C PROCESSING MODULE DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C PROCESSING MODULE FOR SERIAL (B)(6) WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    SECTION A. PATIENT INFORMATION. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE ELEVATED SODIUM WHEN PROCESSING ON ALINITY C PROCESSING MODULE. THE CUSTOMER STATED PATIENT RESULTS SPORADICALLY WERE TOO HIGH FOR SODIUM, SUCH AS 170; 185; 190 MMOL/L. THE PATIENTS WERE NORMAL WHEN REPEATED ON ANOTHER INSTRUMENT: 138; 140; 145 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE ELEVATED SODIUM WHEN PROCESSING ON ALINITY C PROCESSING MODULE. THE CUSTOMER STATED PATIENT RESULTS SPORADICALLY WERE TOO HIGH FOR SODIUM, SUCH AS 170; 185; 190 MMOL/L. THE PATIENTS WERE NORMAL WHEN REPEATED ON ANOTHER INSTRUMENT: 138; 140; 145 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2087687 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown