BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 24713544 · Received March 30, 2026

    Report

    Report Number
    3016438761-2026-00174
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 23, 2026
    Report Date
    April 10, 2026
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    K170317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B1 DESCRIBE EVENT OR PROBLEM WAS UPDATED WITH ADDITIONAL INFORMATION. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION THE ALINITY I PROCESSING MODULE, SERIAL NUMBER (B)(6), WAS FOUND TO HAVE A LESS THAN ADEQUATE AMOUNT OF PRETRIGGER SOLUTION IN ITS RESERVOIR AND GENERATED MESSAGE CODES AS THE SAMPLES CONTINUED TO BE PROCESSED. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL TICKETS RELATED TO ERRATIC/DISCREPANT 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 OF THE ALINITY I FOUND NO SIMILAR ISSUES RELATED TO THE ALINITY SYSTEM OR DISCREPANT RESULTS AS DESCRIBED IN THIS TICKET. A REVIEW OF MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES RELATED TO THE COMPLAINT ISSUE. THE ALINITY CI-SERIES OPERATIONS MANUAL PROVIDES ADEQUATE INFORMATION REGARDING THE TROUBLESHOOTING OF ERRATIC/DISCREPANT RESULTS MESSAGE CODES 3060,1044,1043,1402,1403 AND 1196. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C PROCESSING MODULE, SERIAL (B)(6) WAS IDENTIFIED.

    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 THE PRE-TRIGGER GENERATED AN INVENTORY LEVEL SENSOR ERROR ON THE ALINITY I PROCESSING MODULE AND CONTINUED TO PROCESS SAMPLES THAT GENERATED DISCREPANT RESULTS. THE FOLLOWING INSTRUMENT ERROR MESSAGES AND PATIENT DATA WAS PROVIDED: (B)(6) 2026 AT 10:17: 3060 (PRE-TRIGGER) INVENTORY LEVEL SENSOR ERROR. CURRENT LEVEL SENSOR ADC (1), PREVIOUS LEVEL SENSOR ADC (2) AND ASPIRATION VOLUME (3)1201 MODULE STOPPED, MAXIMUM NUMBER OF OPTICS READ ERRORS EXCEEDED. ADDITIONAL OPTICS ERROR CODES WERE GENERATED: 1044 UNABLE TO CALCULATE RESULT. FINAL RLU READ IS OUTSIDE THE SPECIFICATION OF THE LOWEST CALIBRATOR. 1043 UNABLE TO CALCULATE RESULT. FINAL RUL READ IS OUTSIDE THE SPECIFICATION OF THE HIGHEST CALIBRATOR. 1402 UNABLE TO PROCESS TEST. ACTIVATED READ FAILURE. 1403 UNABLE TO PROCESS TEST. FINAL READ FAILURE. 1196 UNABLE TO PROCESS TEST. NO SIGNAL PEAK. PATIENT DATA: (B)(6) 2026 AT 11:08, SID (B)(6): TSH INITIAL RESULT WAS <0.008 MIU/L, REPEAT = 1.65 MIU/L, (B)(6) 2026 AT 11:09, SID (B)(6): TSH INITIAL RESULT WAS <0.008 MIU/L, REPEAT = 2.88 MIU/L, (B)(6) 2026 AT 12:09, SID (B)(6): INITIAL PROLACTIN RESULT WAS <0.6 NG/ML, REPEAT = 17.8 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. UPDATED INFORMATION WAS PROVIDED: SID (B)(6) IS CORRECTED TO (B)(6): SID (B)(6) IS FROM A 73 YEAR OLD MALE PATIENT. SID (B)(6) IS FROM A 80 YEAR OLD FEMALE PATIENT. SID (B)(6) IS FROM A 60 YEAR OLD FEMALE PATIENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE PRE-TRIGGER GENERATED AN INVENTORY LEVEL SENSOR ERROR ON THE ALINITY I AM PROCESSING MODULE AND CONTINUED TO PROCESS SAMPLES THAT GENERATED DISCREPANT RESULTS. THE FOLLOWING INSTRUMENT ERROR MESSAGES AND PATIENT DATA WAS PROVIDED: 23FEB2026 AT 10:17: 3060 (PRE-TRIGGER) INVENTORY LEVEL SENSOR ERROR. CURRENT LEVEL SENSOR ADC (1), PREVIOUS LEVEL SENSOR ADC (2) AND ASPIRATION VOLUME (3)1201 MODULE STOPPED, MAXIMUM NUMBER OF OPTICS READ ERRORS EXCEEDED. ADDITIONAL OPTICS ERROR CODES WERE GENERATED: 1044 UNABLE TO CALCULATE RESULT. FINAL RLU READ IS OUTSIDE THE SPECIFICATION OF THE LOWEST CALIBRATOR. 1043 UNABLE TO CALCULATE RESULT. FINAL RUL READ IS OUTSIDE THE SPECIFICATION OF THE HIGHEST CALIBRATOR. 1402 UNABLE TO PROCESS TEST. ACTIVATED READ FAILURE. 1403 UNABLE TO PROCESS TEST. FINAL READ FAILURE. 1196 UNABLE TO PROCESS TEST. NO SIGNAL PEAK. PATIENT DATA: (B)(6) 2026 AT 11:08, SID (B)(6): TSH INITIAL RESULT WAS <0.008 MIU/L, REPEAT = 1.65 MIU/L (B)(6) 2026 AT 11:09, SID (B)(6): TSH INITIAL RESULT WAS <0.008 MIU/L, REPEAT = 2.88 MIU/L (B)(6) 2026 AT 12:09, SID (B)(6): INITIAL PROLACTIN RESULT WAS <0.6 NG/ML, REPEAT = 17.8 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374304 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1