BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 23887472 · Received December 24, 2025

    Report

    Report Number
    3016438761-2025-00767
    Event Type
    Malfunction
    Date Received
    December 24, 2025
    Date of Event
    December 6, 2025
    Report Date
    January 13, 2026
    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

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETED INFORMATION FOR SECTION A1 - PATIENT IDENTIFIER: SIDS (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION SECTION H4 - DEVICE MFR DATE. THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT, PERFORMED TROUBLESHOOTING, AND REPLACED THE TUBING, PERISTALTIC HEAD WHICH RESOLVED THE ISSUE. AN INSTRUMENT SERVICE HISTORY REVIEW FOR (B)(6) REVEALED NO ADDITIONAL TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC RESULTS. THERE WERE NO ADDITIONAL SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE ALINITY C PROCESSING MODULE WITH REGARDS TO THE CUSTOMER REPORTED EVENT. ADDITIONALLY REVIEW OF COMPLAINT AND TRENDING DATA ASSOCIATED WITH THE TUBING, PERISTALTIC HEAD DID NOT IDENTIFY ANY TRENDS. REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6), OR THE TUBING, PERISTALTIC HEAD WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED CREATININE AND T-BILI RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED: ID (B)(6) CREATININE INITIAL RESULT = 1.6 MG/DL, CORRECTED RESULT = 3.47 MG/DL. ID (B)(6) CREATININE INITIAL RESULT = 0.73 MG/DL, CORRECTED RESULT = 2.13. MG/DL (CUSTOMER¿S T BILI REFERENCE RANGE 0.2 - 1.0 MG/DL) ID (B)(6) T BILI INITIAL RESULT = <0.1 MG/DL, CORRECTED RESULT = 0.2. MG/DL ID (B)(6) T BILI INITIAL RESULT = <0.1 MG/DL, CORRECTED RESULT = 0.2 MG/DL. ID (B)(6) T BILI INITIAL RESULT = <0.1 MG/DL, CORRECTED RESULT = 0.2 MG/DL. ID (B)(6) T BILI INITIAL RESULT = <0.1 MG/DL, CORRECTED RESULT = 0.2 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED CREATININE AND T-BILI RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED: ID (B)(6) CREATININE INITIAL RESULT = 1.6 MG/DL, CORRECTED RESULT = 3.47 MG/DL, ID (B)(6) CREATININE INITIAL RESULT = 0.73 MG/DL, CORRECTED RESULT = 2.13 MG/DL. (CUSTOMER¿S T BILI REFERENCE RANGE 0.2 - 1.0 MG/DL). ID (B)(6) T BILI INITIAL RESULT = <0.1 MG/DL, CORRECTED RESULT = 0.2 MG/DL, ID (B)(6) T BILI INITIAL RESULT = <0.1 MG/DL, CORRECTED RESULT = 0.2 MG/DL, ID (B)(6) T BILI INITIAL RESULT = <0.1 MG/DL, CORRECTED RESULT = 0.2 MG/DL, ID (B)(6) T BILI INITIAL RESULT = <0.1 MG/DL, CORRECTED RESULT = 0.2 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057987 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALIN TTL BILI2 3500T, 04U05-20.| ALNTY C CREAT2 4500T, 04T91-20.