BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 18948683 · Received March 21, 2024

    Report

    Report Number
    3016438761-2024-00169
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    March 13, 2024
    Report Date
    April 3, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION IN SECTION D4 PRIMARY UDI NUMBER THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ALINITY C PROCESSING MODULE AND RESOLVED THE ISSUE BY REPLACING THE 1ML SYRINGE. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. THE 1ML SYRINGE WAS DETERMINED TO BE THE LIKELY CAUSE OF THE ISSUE. REVIEW OF ALL THE INFORMATION PROVIDED BY THE CUSTOMER WAS REVIEWED. THE INSTRUMENT SERVICE HISTORY REVIEW 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 DID NOT IDENTIFY ANY TRENDS FOR THE 1ML SYRINGE. REVIEW OF THE CLINICAL CHEMISTRY SYSTEMS PRODUCT MONITORING REVIEW SCORECARD FOUND NO TRENDS WITH REGARDS TO THE CURRENT ISSUE RELATED TO THE ALINITY C SYSTEM, LIKELY CAUSE PART, OR DISCREPANT RESULTS AS DESCRIBED IN THIS TICKET. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR ANY POTENTIAL NON-CONFORMANCES. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C PROCESSING MODULE FOR SERIAL NUMBER (B)(6)WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED SODIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR MULTIPLE SAMPLES. THE FOLLOWING EXAMPLE RESULTS WERE PROVIDED: (CUSTOMER PROVIDED PATIENT NORMAL RANGE 152-168 MMOL/L) 13MAR2024 SID (B)(6) INITIAL RESULT 164 MMOL/L, REPEAT RESULT WAS 124 MMOL/L, REPEATED ON ANOTHER INSTRUMENT 142 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 FOR MULTIPLE SAMPLES. THE FOLLOWING EXAMPLE RESULTS WERE PROVIDED: (CUSTOMER PROVIDED PATIENT NORMAL RANGE 152-168 MMOL/L) ON (B)(6 2024, SID (B)(6), INITIAL RESULT 164 MMOL/L, REPEAT RESULT WAS 124 MMOL/L, REPEATED ON ANOTHER INSTRUMENT 142 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892485 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 1ML SYRINGE, 09D41-03, UNKNOWN| 1ML SYRINGE, 09D41-03, UNKNOWN