BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 18499148 · Received January 11, 2024

    Report

    Report Number
    3016438761-2024-00019
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    December 22, 2023
    Report Date
    January 25, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H4 - DEVICE MFG DATE: UPDATED FROM BLANK TO 1/25/2021 THE ALINITY C ICT CHECK VALVE WAS REPLACED WHICH RESOLVED THE ISSUE AS NO ADDITIONAL DISCREPANT RESULTS HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. AN INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED FOR (B)(6). THERE WERE NO 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 OF THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6)DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ICT CHECK VALVE, DID NOT IDENTIFY ANY TRENDS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES FOR THE COMPLAINT ISSUE. 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 (B)(6), OR THE ICT CHECK VALVE WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL 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 DECREASED SODIUM (NA+) RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 133-147 MMOL/L): INITIAL RESULT = 118 MMOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT = 135 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED SODIUM (NA+) RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 133-147 MMOL/L): INITIAL RESULT = 118 MMOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT = 135 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2003271 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY C ICT SAMPLE DILU, 07P53-20, (B)(6)| ALNTY C ICT SAMPLE DILU, 07P53-20, (B)(6)| ICT CHECK VALVE, 09D35-03, UNKNOWN| ICT CHECK VALVE, 09D35-03, UNKNOWN