BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 22014164 · Received May 13, 2025

    Report

    Report Number
    3016438761-2025-00286
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    May 1, 2025
    Report Date
    June 25, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    K170316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. TROUBLESHOOTING PERFORMED BY THE SERVICE ENGINEER INCLUDED REPLACEMENT OF THE ICT TO ICT PRE AMP CABLE WHICH RESOLVED THE ISSUE. THE MODULE FUNCTION WAS VERIFIED WITH A PASSING QC RUN. NO ADDITIONAL RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. THE SERVICE HISTORY OF THE ALINITY C PROCESSING MODULE, SERIAL # (B)(6) RETURNED NO ADDITIONAL TICKETS FOR DISCREPANT/ERRATIC SODIUM PATIENT RESULTS. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS FOR THE ICT TO ICT PRE AMP CABLE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    A1 PATIENT IDENTIFIER: COMPLETE SAMPLE IS ID (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 REPORTED FALSELY ELEVATED SODIUM GENERATED FROM ALINITY C PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE ID (B)(6), INITIAL RESULT WAS 160 AND REPEAT RESULT WAS 146 (CUSTOMER REFERENCE RANGE 133 -146 MMOL/L). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED SODIUM GENERATED FROM ALINITY C PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE ID (B)(6), INITIAL RESULT WAS 160 AND REPEAT RESULT WAS 146 (CUSTOMER REFERENCE RANGE 133 -146 MMOL/L). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879988 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown