BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 20438011 · Received October 14, 2024

    Report

    Report Number
    3016438761-2024-00601
    Event Type
    Malfunction
    Date Received
    October 14, 2024
    Date of Event
    September 23, 2024
    Report Date
    November 11, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR A FALSELY DECREASED ALINITY C SODIUM AND POTASSIUM RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, LABELING REVIEW, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, AND DEVICE HISTORY RECORD REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TICKETS DETERMINED THERE IS NORMAL COMPLAINT ACTIVITY. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. MANUFACTURING DOCUMENTATION (DEVICE HISTORY RECORD) FOR THE LIKELY CAUSE DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE AVAILABLE INFORMATION, NO DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY DECREASED SODIUM AND POTASSIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE ON MULTIPLE PATIENTS. THE FOLLOWING EXAMPLE RESULT WAS PROVIDED ON ONE PATIENT: (B)(6) 2024 = 112, ANOTHER INSTRUMENT = 139 / 140 (NORMAL RANGE: 134-146). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY DECREASED SODIUM AND POTASSIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE ON MULTIPLE PATIENTS. THE FOLLOWING EXAMPLE RESULT WAS PROVIDED ON ONE PATIENT: (B)(6) 2024 = 112, ANOTHER INSTRUMENT = 139 / 140 (NORMAL RANGE: 134-146). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1873385 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALINITY C ICT SERUM CAL, 08P69-01, 10020UN24| ALINITY C ICT SERUM CAL, 08P69-01, 10020UN24