BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 24181602 · Received January 26, 2026

    Report

    Report Number
    3016438761-2026-00045
    Event Type
    Malfunction
    Date Received
    January 26, 2026
    Date of Event
    January 6, 2026
    Report Date
    March 2, 2026
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    K170316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND DETERMINED THAT THE PROBES INSIDE THE ICT REFERENCE CUP WERE SLIGHTLY BENT. THE FSR REPLACED THE DAMAGED ICT REFERENCE CUP WITH PROBES, WHICH RESOLVED THE ISSUE. A REVIEW OF INSTRUMENT SERVICE HISTORY FOR SERIAL NUMBER (B)(6) REVEALED THAT NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. A REVIEW OF COMPLAINT AND TRENDING DATA FOR THE ALINITY C PROCESSING MODULE DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY ASSOCIATED WITH THE COMPLAINT ISSUE. ADDITIONALLY, A REVIEW OF COMPLAINT AND TRENDING DATA ASSOCIATED WITH THE ICT REFERENCE CUP WITH PROBES DID NOT IDENTIFY ANY TRENDS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6), OR THE ICT REFERENCE CUP WITH PROBES.

    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 OBSERVED DEPRESSED SODIUM (NA) RESULTS WHEN PROCESSING ON THE ALINITY C PROCESSING MODULE. AN EXAMPLE WAS PROVIDED. PATIENT B: YESTERDAY SAMPLE: NA OF 140 MMOL/L, BUT TODAY SAMPLE: NA OF 120 MMOL/L, REPEAT TODAY SAMPLE NA OF 125 MMOL/L. CUSTOMER NORMAL RANGE 136 - 145 MMOL/L. OVERNIGHT QUALITY CONTROL VALUES WERE BOTH IN AND OUTSIDE THE RANGE, BUT CUSTOMER STATING CONTROLS WERE IN RANGE WITH NO ISSUES. QC LEVEL 1: 124/112/122/111/111, LAB RANGE 106 ¿ 117 MMOL/L. QC LEVEL 3: 169/171/155/149/157, LAB RANGE 151 ¿ 169 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DEPRESSED SODIUM (NA) RESULTS WHEN PROCESSING ON THE ALINITY C PROCESSING MODULE. AN EXAMPLE WAS PROVIDED. PATIENT B: YESTERDAY SAMPLE: NA OF 140 MMOL/L, BUT TODAY SAMPLE: NA OF 120 MMOL/L, REPEAT TODAY SAMPLE NA OF 125 MMOL/L. CUSTOMER NORMAL RANGE 136 - 145 MMOL/L. OVERNIGHT QUALITY CONTROL VALUES WERE BOTH IN AND OUTSIDE THE RANGE, BUT CUSTOMER STATING CONTROLS WERE IN RANGE WITH NO ISSUES. QC LEVEL 1: 124/112/122/111/111, LAB RANGE 106 ¿ 117 MMOL/L. QC LEVEL 3: 169/171/155/149/157, LAB RANGE 151 ¿ 169 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65504 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown