BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 21650710 · Received March 20, 2025

    Report

    Report Number
    3016438761-2025-00176
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Date of Event
    March 3, 2025
    Report Date
    March 26, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    K170316
    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

    ABBOTT FIELD SERVICE (FS) INVESTIGATED THE ISSUE ON SITE. FS TROUBLESHOOTING INCLUDED REPLACING THE ICT PRE AMP CABLE WHICH RESOLVED THE ISSUE. THERE HAVE BEEN NO FURTHER REPORTS OF DISCREPANT RESULTS SINCE THE PART WAS REPLACED. A REVIEW OF THE ALINITY C PROCESSING MODULE SN# (B)(6) SERVICE HISTORY WAS NOT ABLE TO IDENTIFY OR CONFIRM ANY ADDITIONAL LIKELY CAUSES. A REVIEW OF HISTORICAL DATA REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NONCONFORMANCES. A REVIEW OF THE CLINICAL CHEMISTRY SYSTEMS REVEALED FOUND NO SYSTEMIC ISSUES OR TRENDS FOR THE ISSUE ASSOCIATED WITH THIS TICKET (ERRATIC/DISCREPANT RESULTS). A REVIEW OF LABELLING ADEQUATELY ADDRESSES SAMPLE RESULTS OBSERVED PROBLEMS FOR ERRATIC / DISCREPANT RESULTS. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY C PROCESSING MODULE SN# (B)(6).

    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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED SODIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE ON TWO PATIENTS. RESULTS PROVIDED: PATIENT 1 = 175/ 136 MMOL/L, PATIENT 2 = 200 / 140 MMOL/L , NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED SODIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE ON TWO PATIENTS. RESULTS PROVIDED: PATIENT 1 = 175/ 136 MMOL/L. PATIENT 2 = 200 / 140 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372833 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, (B)(6)| ALNTY C ICT SAMPLE DILU, 07P53-20, (B)(6)