BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 23116571 · Received September 22, 2025

    Report

    Report Number
    3016438761-2025-00547
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    August 14, 2025
    Report Date
    October 16, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    K170317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10. CONCOMITANT PRODUCT IS UPDATED. AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND REPLACED THE ALNTY CI SNSR BSL. RESOLVING THE ISSUE. THE INSTRUMENT SERVICE HISTORY REVIEW FOR (B)(6) REVEALED NO ADDITIONAL SERVICE 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 FOR THE ALINITY I-SERIES PROCESSING MODULE DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. A REVIEW OF TRACKING AND TRENDING FOR THE ALNTY CI SNSR BSL DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I-SERIES PROCESSING MODULE FOR SERIAL (B)(6) OR THE ALNTY CI SNSR BSL WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    SECTION A PATIENT INFORMATION: PATIENT IDENTIFIER OF MULTIPLE IS(B)(6). NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE DEPRESSED RESULTS WHEN PROCESSING ON THE ALINITY I PROCESSING MODULE. ON (B)(6) 2025, PATIENT RESULTS WERE GENERATED WHILE THE PRETRIGGER RESERVOIR WAS EMPTY. AT 19:07 THE INSTRUMENT STOPPED WITH AN ERROR RELATED TO THE PRETRIGGER LEVEL SENSOR ERROR CODE 3060. THE LAB REINITIALIZED THE INSTRUMENT, MOST OF THE RESULTS AFTER THE EVENT DID NOT PRODUCE A RESULT, DUE TO NO OPTICS OR LOW OPTICS READS, HOWEVER 3 RESULTS WERE GENERATED. DATE/TIME; ID; ASSAY RESULT: (B)(6) 2025 20:20:40; (B)(6); CEA < 0.5 NG/ML. (B)(6) 2025 20:22:46; (B)(6); CA 125 II < 1.0 U/ML. (B)(6) 2025 21:20:28; (B)(6); TSH < 0.0100 UIU/ML. RERUN RESULTS NEXT DAY: DATE/TIME ID MODULE ASSAY RESULT (B)(6) 2025 14:16:27; (B)(6) CEA 3.6 NG/ML. (B)(6) 2025 14:16:44; (B)(6) CA 125 II 278.8 U/ML. (B)(6) 2025 14:18:26; (B)(6) TSH 2.6162 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE DEPRESSED RESULTS WHEN PROCESSING ON THE ALINITY I PROCESSING MODULE. ON (B)(6) 2025, PATIENT RESULTS WERE GENERATED WHILE THE PRETRIGGER RESERVOIR WAS EMPTY. AT 19:07 THE INSTRUMENT STOPPED WITH AN ERROR RELATED TO THE PRETRIGGER LEVEL SENSOR ERROR CODE 3060. THE LAB REINITIALIZED THE INSTRUMENT, MOST OF THE RESULTS AFTER THE EVENT DID NOT PRODUCE A RESULT, DUE TO NO OPTICS OR LOW OPTICS READS, HOWEVER 3 RESULTS WERE GENERATED. DATE/TIME; ID; ASSAY RESULT. (B)(6) 2025 20:20:40; (B)(6); CEA < 0.5 NG/ML. (B)(6) 2025 20:22:46; (B)(6); CA 125 II < 1.0 U/ML. (B)(6) 2025 21:20:28; (B)(6); TSH < 0.0100 UIU/ML. RERUN RESULTS NEXT DAY: DATE/TIME; ID MODULE; ASSAY RESULT. (B)(6) 2025 14:16:27; (B)(6); CEA 3.6 NG/ML. (B)(6) 2025 14:16:44; (B)(6); CA 125 II 278.8 U/ML. (B)(6) 2025 14:18:26; (B)(6); TSH 2.6162 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE DEPRESSED RESULTS WHEN PROCESSING ON THE ALINITY I PROCESSING MODULE. ON (B)(6) 2025, PATIENT RESULTS WERE GENERATED WHILE THE PRETRIGGER RESERVOIR WAS EMPTY. AT 19:07 THE INSTRUMENT STOPPED WITH AN ERROR RELATED TO THE PRETRIGGER LEVEL SENSOR ERROR CODE 3060. THE LAB REINITIALIZED THE INSTRUMENT, MOST OF THE RESULTS AFTER THE EVENT DID NOT PRODUCE A RESULT, DUE TO NO OPTICS OR LOW OPTICS READS, HOWEVER 3 RESULTS WERE GENERATED. DATE/TIME: ID : ASSAY RESULT: ON (B)(6) 2025, 20:20:40 , (B)(6), CEA < 0.5 NG/ML. ON (B)(6) 2025, 20:22:46, (B)(6), CA 125 II < 1.0 U/ML. ON (B)(6) 2025, 21:20:28, (B)(6), TSH < 0.0100 UIU/ML. RERUN RESULTS NEXT DAY: DATE/TIME: ID MODULE : ASSAY RESULT: ON (B)(6) 2025, 14:16:27, (B)(60, CEA 3.6 NG/ML. ON (B)(6) 2025, 14:16:44, (B)(6), CA 125 II 278.8 U/ML. ON (B)(6) 2025, 14:18:26, (B)(6), TSH 2.6162 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532712 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALIN I CEA RGT KIT 200T, 07P62-20.| ALIN I CEA RGT KIT 200T, 07P62-20.| ALINITY I TSH LIST 7P48-30, CEA, CA125.| ALNTY I CA 125 II 200T, 08P49-20.| ALNTY I CA 125 II 200T, 08P49-20.| ALNTY I TSH RGT 1200T K, 07P48-30, 71332UD00.| ALNTY I TSH RGT 1200T K, 07P48-30, 71332UD00.