BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 17685617 · Received September 5, 2023

    Report

    Report Number
    3016438761-2023-00475
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 15, 2023
    Report Date
    September 15, 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

    AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED DUE TO THE CUSTOMER REPORTING FALSELY DECREASED SODIUM RESULTS ON AN ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6). THROUGH AN EXTENSIVE INVESTIGATION, THE FSR FOUND THAT THE DISCREPANT RESULTS WERE FROM CUVETTE #97. THE FSR RESOLVED THE ISSUE BY REPLACING THE CUVETTE SEGMENT, LIST NUMBER 04S47-01 ALNTY C-SERIES CUVETTE, CONTAINING CUVETTE #97. NO SUBSEQUENT ISSUES HAVE BEEN REPORTED. A REVIEW OF THE INSTRUMENT HISTORY REVEALED NO CONTRIBUTING FACTORS DESCRIBED IN THIS COMPLAINT. A REVIEW OF LABELING AND HISTORICAL DATA WAS DONE, AND BOTH WERE ADEQUATE, WITH NO TRENDS FOUND. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A1 - PATIENT IDENTIFIER COMPLETE ENTRY = PATIENT 1, PATIENT 3, AND SAMPLE ID (B)(6) . ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED SODIUM RESULTS FOR THREE PATIENTS ON AN ALINITY C ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 133-146 MMOL/L): PATIENT 1 INITIAL RESULT WAS 100.4 MMOL/L, REPEAT WAS 137.7 MMOL/L PATIENT 3 INITIAL RESULT 104 MMOL/L, REPEAT WAS NORMAL SAMPLE ID (B)(6) INITIAL RESULT WAS 111, REPEAT WAS 136 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED SODIUM RESULTS FOR THREE PATIENTS ON AN ALINITY C ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 133-146 MMOL/L): PATIENT 1 INITIAL RESULT WAS 100.4 MMOL/L, REPEAT WAS 137.7 MMOL/L. PATIENT 3 INITIAL RESULT 104 MMOL/L, REPEAT WAS NORMAL. SAMPLE ID (B)(6) INITIAL RESULT WAS 111, REPEAT WAS 136 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560966 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown