BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 19595643 · Received June 24, 2024

    Report

    Report Number
    3016438761-2024-00371
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    June 10, 2024
    Report Date
    July 15, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR INSPECTED THE INSTRUMENT, PERFORMED QUARTERLY AND TRIANNUAL MAINTENANCE, AND REPLACED MULTIPLE PARTS TO RESOLVE THE ISSUE. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. LIST NUMBER 09D28-04 ICT MODULE/ LOT 240117 WAS DETERMINED TO BE THE LIKELY CAUSE OF THE ISSUE. THERE WERE NO SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. AN INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED FOR (B)(6). A REVIEW OF TRACKING AND TRENDING OF THE ALINITY C PROCESSING MODULE AND THE 09D28-04 ICT MODULE DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. 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, SERIAL NUMBER (B)(6) OR THE 09D28-04 ICT MODULE WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM (NA) RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6), FOR 4 PATIENTS. THE RESULTS WERE NOT REPORTED OUT. THE SAMPLES WERE REPEATED ON ANOTHER INSTRUMENT WITH HIGHER RESULTS. THE FOLLOWING DATA WAS PROVIDED: NO SPECIFIC PATIENT RESULTS WERE PROVIDED BUT INITIAL RESULTS WERE AROUND 110 AND REPEATED AROUND 136 MMOL/L. REFERENCE RANGE = 136-145 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM (NA) RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6) , FOR 4 PATIENTS. THE RESULTS WERE NOT REPORTED OUT. THE SAMPLES WERE REPEATED ON ANOTHER INSTRUMENT WITH HIGHER RESULTS. THE FOLLOWING DATA WAS PROVIDED: NO SPECIFIC PATIENT RESULTS WERE PROVIDED BUT INITIAL RESULTS WERE AROUND 110 AND REPEATED AROUND 136 MMOL/L. REFERENCE RANGE = 136-145 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655505 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, 240117323