BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 19407126 · Received May 28, 2024

    Report

    Report Number
    3016438761-2024-00318
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    May 9, 2024
    Report Date
    June 20, 2024
    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 EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW AND LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES RELATED TO THE COMPLAINT ISSUE. REVIEW OF PRODUCT LABELING FOUND ADEQUATE INFORMATION REGARDING THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR TWO PATIENTS. THE RESULTS WERE NOT REPORTED OUT THE LAB. THE FOLLOWING DATA FROM 09MAY2024 WAS PROVIDED (REFERENCE RANGE 133-146 MMOL/L): SID (B)(6) INITIAL RESULT <100, REPEAT 137 MMOL/L SID (B)(6) INITIAL RESULT 141, REPEAT 117 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR TWO PATIENTS. THE RESULTS WERE NOT REPORTED OUT THE LAB. THE FOLLOWING DATA FROM (B)(6) 2024 WAS PROVIDED (REFERENCE RANGE 133-146 MMOL/L): SID (B)(6) INITIAL RESULT 100, REPEAT 137 MMOL/L. SID (B)(6) INITIAL RESULT 141, REPEAT 117 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2378583 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 ICT SAMPLE DILU, 07P53-20, 17993UN23