BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 16773137 · Received April 19, 2023

    Report

    Report Number
    3016438761-2023-00217
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    March 24, 2023
    Report Date
    May 5, 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

    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.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSELY DEPRESSED SODIUM RESULTS WHEN USING ALINITY C ICT SAMPLE DILUENT (LN 7P53-20) LOT 36568UN22 ON ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6) INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TRACKING AND TRENDING DATA DID NOT IDENTIFY ANY TRENDS RELATED TO THE CURRENT COMPLAINT ISSUE. A REVIEW OF DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LIST NUMBER/LOT NUMBER AND COMPLAINT ISSUE. FILE SAMPLE ANALYSIS WAS NOT PERFORMED. AS PART OF TROUBLESHOOTING, THE SUSPECT SAMPLES WERE RETESTED GIVING HIGHER RESULTS. QC WAS ACCEPTABLE, INDICATING THE ASSAY IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC SYSTEM OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6) AND THE ALINITY C ICT SAMPLE DILUENT (LN 7P53-20) LOT 36568UN22.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY DEPRESSED SODIUM (NA) RESULTS FOR ONE PATIENT SAMPLE WHILE RUNNING ON THE ALINITY C PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: SID 0315991: INITIAL NA RESULT = 119 MMOL/L; REPEAT RESULT: 137.5 MMOL/L THE CUSTOMER¿S NORMAL REFERENCE RANGE FOR SODIUM IS 133-146 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY DEPRESSED SODIUM (NA) RESULTS FOR ONE PATIENT SAMPLE WHILE RUNNING ON THE ALINITY C PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL NA RESULT = 119 MMOL/L; REPEAT RESULT: 137.5 MMOL/L. THE CUSTOMER¿S NORMAL REFERENCE RANGE FOR SODIUM IS 133-146 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1936528 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY C ICT SAMPLE DILU, 07P53-20, 36568UN22.