BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 21767656 · Received April 3, 2025

    Report

    Report Number
    3016438761-2025-00207
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 20, 2025
    Report Date
    April 17, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    K170316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETED INFORMATION FOR SECTION A1 - PATIENT IDENTIFIER: SIDS (B)(6) THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 03R67, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US WITH THE SAME LIST NUMBER, AND A 510K/PMA/BLA NUMBER OF K170316. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION SECTION H4 - DEVICE MFG DATE: UPDATED FROM BLANK TO 2/1/2023. THE ICT MODULE IN USE WITH THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6) WAS ASSESSED DUE TO FALSE ELEVATED SODIUM RESULTS, AND IT WAS DETERMINED THAT THE ICT MODULE REQUIRED REPLACEMENT. THE REPLACEMENT OF THE ICT MODULE RESOLVED THE ISSUE. NO SUBSEQUENT ISSUES HAVE BEEN REPORTED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE INSTRUMENT SERVICE HISTORY REVIEW FOR (B)(6) REVEALED NO ADDITIONAL SERVICE TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC RESULTS. A REVIEW OF COMPLAINT AND TRENDING DATA FOR THE ALINITY C PROCESSING MODULE AND ICT MODULE DID NOT IDENTIFY ANY SIMILAR ISSUES AS DESCRIBED IN THIS COMPLAINT. A REVIEW OF THE INSTRUMENT HISTORY REVEALED NO CONTRIBUTING FACTORS DESCRIBED IN THIS COMPLAINT. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES RELATED TO THE CURRENT COMPLAINT. REVIEW OF THE PRODUCT MONITORING REVIEW FOR CLINICAL CHEMISTRY SYSTEMS DID NOT IDENTIFY ANY SIMILAR ISSUES RELATED TO THE ALINITY C SYSTEM, LIKELY CAUSE PART, OR DISCREPANT RESULTS AS DESCRIBED IN THIS COMPLAINT. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6), OR THE ICT MODULE WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED SODIUM (NA) RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 136-145 MMOL/L): SAMPLE ID (B)(6) INITIAL RESULT = 174.3 MMOL/L, REPEAT RESULT ON ANOTHER ALINITY = 138.6 MMOL/L. SAMPLE ID (B)(6) INITIAL RESULT = 197.5 MMOL/L, REPEAT RESULT ON ANOTHER ALINITY = 124.1 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED SODIUM (NA) RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 136-145 MMOL/L): SAMPLE ID (B)(6), INITIAL RESULT = 174.3 MMOL/L, REPEAT RESULT ON ANOTHER ALINITY = 138.6 MMOL/L. SAMPLE ID (B)(6), INITIAL RESULT = 197.5 MMOL/L, REPEAT RESULT ON ANOTHER ALINITY = 124.1 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445768 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ICT MODLE, 09D28-04, 240713381| ICT MODLE, 09D28-04, 240713381