BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 19495239 · Received June 9, 2024

    Report

    Report Number
    3016438761-2024-00342
    Event Type
    Malfunction
    Date Received
    June 9, 2024
    Date of Event
    May 28, 2024
    Report Date
    June 19, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND RESOLVED THE ISSUE BY ADJUSTING THE PUMP, NRD-30 MAG., CUVETTE AND WASH CUPS, N. S. AS THE CUVETTE WASHER FLOW WAS LOW. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. 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. 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 FOR THE ALINITY C PROCESSING MODULE DID NOT IDENTIFY ANY TRENDS. A REVIEW OF TRACKING AND TRENDING FOR THE PUMP, NRD-30 MAG., CUVETTE AND WASH CUPS, N. S. DID NOT IDENTIFY ANY TRENDS. REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C PROCESSING MODULE FOR SERIAL (B)(6) OR THE PUMP, NRD-30 MAG., CUVETTE AND WASH CUPS, N. S. WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    COMPLETED INFORMATION FOR SECTION A1 PATIENT IDENTIFIER: (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. 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 A FALSELY DEPRESSED ALINITY C GLUCOSE RESULT FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 13 MG/DL, REPEAT = 123 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DEPRESSED ALINITY C GLUCOSE RESULT FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). INITIAL RESULT = 13 MG/DL, REPEAT = 123 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2125761 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY C GLUCOSE 400T, 07P55-20, (B)(6) | ALNTY C GLUCOSE 400T, 07P55-20, (B)(6)