BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 17239110 · Received June 30, 2023

    Report

    Report Number
    3016438761-2023-00357
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    June 13, 2023
    Report Date
    July 31, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    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 CUSTOMER RESOLVED THE ISSUE BY REPLACING THE ICT MODULE. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE ICT MODULE WAS REPLACED. LIST NUMBER 09D28-04 ICT MODULE/LOT 230216 WAS DETERMINED TO BE THE LIKELY CAUSE OF THE ISSUE. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC PATIENT 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. TRENDING DATA WAS REVIEWED AND DID NOT IDENTIFY ANY RELATED TRENDS FOR THE ICT MODLE (09D28-04). NO SIMILAR ISSUES RELATED TO THE ALINITY SYSTEM, LIKELY CAUSE PARTS, OR DISCREPANT RESULTS AS DESCRIBED IN THIS TICKET WERE IDENTIFIED. THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS RELATED TO THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6) OR THE ICT MODULE.

    Additional Manufacturer Narrative · 0

    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 FALSELY ELEVATED SODIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6). THE SAMPLE WAS REPEATED ON ANOTHER ALINITY, SERIAL NUMBER (B)(6) AND THE RESULT WAS LOWER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 167 MMOL/L REPEAT RESULT = 144 MMOL/L. SODIUM REFERENCE RANGE: 133 - 146 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED SODIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6). THE SAMPLE WAS REPEATED ON ANOTHER ALINITY, SERIAL NUMBER (B)(6) AND THE RESULT WAS LOWER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 167 MMOL/L REPEAT RESULT = 144 MMOL/L. SODIUM REFERENCE RANGE: 133 - 146 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476697 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ICT MODLE, 09D28-04, 230216030| ICT MODLE, 09D28-04, 230216030