BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 22385973 · Received July 2, 2025

    Report

    Report Number
    3016438761-2025-00377
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    May 28, 2025
    Report Date
    September 24, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    PMA / PMN Number
    K170317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTION B5 - DESCRIBE EVENT OR PROBLEM: UPDATE: ADDITIONAL INFORMATION PROVIDED ON 09SEP2025. THE CUSTOMER PROVIDED THE ADDITIONAL DATA INFORMATION: PATIENT 2 WITH SID (B)(6) REPEATED 11 TIMES WITH RESULT = < 2.3 IU/L PATIENT 3 WITH SID (B)(6) REPEATED 5 TIMES WITH THE RESULT =< 2.3 IU/L, AND 7.95 IU/L, SAMPLE WITH SID (B)(6) REPEAT RESULTS =39.75 IU/L, 3.94 AND 2.47 IU/L, REPEATED 7 TIMES = < 2.3 IU/L AN ADDITIONAL PATIENT WAS PROVIDED WITH SID (B)(6) (B)(6) 2025 INITIAL RESULT =32 IU/L /REPEATED ON (B)(6) 2025=32 IU/L, SAME PATIENT REDRAWN AND REPEATED WITH SID (B)(6) ON (B)(6) 2025=20 IU/L /REPEATED ON (B)(6) 2025=19.41 IU/L, THE SAME PATIENT REDRAWN AND REPEATED WITH SID (B)(6) ON (B)(6) 2025 = 23 IU/L /REPEATED ON (B)(6) 2025=3.84, 3.99, 3.63, 4.45, 3.73, 3.84, 6.46, 6.73, 5.84, 5.46 AND 5.8 IU/L (< OR =5.0 IU/L=NEGATIVE).

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID=(B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    DURING THE SITE VISIT, THE ABBOTT FIELD SERVICE (FSR) REPLACED ASSY, ITV (ROHS)_PART NUMBER 7-76656-07, WHICH RESOLVED THE ISSUE. A REVIEW OF THE ALINITY (B)(6) INSTRUMENT SERVICE HISTORY, IDENTIFIED NO CONTRIBUTING FACTORS TO THE DISCREPANT RESULT. 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 COMPLAINT AND TRENDING DATA FOR THE ALINITY I PROCESSING MODULE DID NOT IDENTIFY ANY SIMILAR ISSUES AS DESCRIBED IN THIS COMPLAINT. ADDITIONALLY REVIEW OF COMPLAINT AND TRENDING DATA ASSOCIATED WITH THE ASSY, ITV (ROHS) DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. THE ALINITY CI-SERIES OPERATIONS MANUAL PROVIDES ADEQUATE LABELING WITH REGARDS TO MAINTENANCE AND TROUBLESHOOTING THE ISSUE, INCLUDING OPERATIONAL PRECAUTIONS AND LIMITATIONS; SPECIMEN HANDLING RECOMMENDATIONS AND FLUIDIC SUBSYSTEMS TROUBLESHOOTING AND THE SYSTEM TECHNOLOGY LIMITATIONS AND RESOLVING THE CUSTOMER¿S ISSUE. THE ALINITY I SERVICE DOCUMENTATION CONTAINED ADEQUATE INFORMATION FOR THE TROUBLESHOOTING, REMOVAL, AND REPLACEMENT OF THE ASSY, ITV (ROHS)_PART NUMBER 7-76656-07. A REVIEW OF THE ALINITY I, PROCESSING MODULE TRACKING, AND TRENDING DATA REVEALED NO SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH THE DISCREPANT RESULT DESCRIBED IN THIS COMPLAINT. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ALINITY I PROCESSING MODULE, SERIAL NUMBER (B)(6), OR THE ASSY, ITV (ROHS).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I B-HCG RESULTS ON MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: PATIENT 1: ON (B)(6) 2025: SID (B)(6): INITIAL= 50 IU/L (> 25.0 IU/L =POSITIVE). ON (B)(6) 2025: SID (B)(6): REDRAWN AND REPEATED = NEGATIVE (NO ACTUAL RESULT PROVIDED). ON (B)(6) 2025: REPEATED = < 2.3 IU/L (< OR =5.0 MIU/ML=NEGATIVE). PATIENT 2: ON (B)(6) 2025: SID (B)(6): INITIAL= 33 IU/L. REPEAT FROM SERUM BANK SPECIMEN = NEGATIVE (NO ACTUAL RESULT PROVIDED). REDRAWN AND REPEATED SID (B)(6): = < 5.0 IU/L. PATIENT 3: ON (B)(6) 2025: SID (B)(6): INITIAL= 47 IU/L. REPEAT FROM SERUM BANK SPECIMEN = 47 IU/L. ON (B)(6) 2025: SID (B)(6): REDRAWN AND REPEATED = < 5.0 IU/L. REPEAT FROM SERUM BANK SPECIMEN SID (B)(6): = 39.75 IU/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. UPDATE: ADDITIONAL INFORMATION PROVIDED ON 09SEP2025. THE CUSTOMER PROVIDED THE ADDITIONAL DATA INFORMATION: PATIENT 2 WITH SID (B)(6) REPEATED 11 TIMES WITH RESULT = < 2.3 IU/L. PATIENT 3 WITH SID (B)(6) REPEATED 5 TIMES WITH THE RESULT =< 2.3 IU/L, AND 7.95 IU/L, SAMPLE WITH SID (B)(6) REPEAT RESULTS =39.75 IU/L, 3.94 AND 2.47 IU/L, REPEATED 7 TIMES = < 2.3 IU/L. AN ADDITIONAL PATIENT WAS PROVIDED WITH SID (B)(6) ON (B)(6) 2025 INITIAL RESULT =32 IU/L /REPEATED ON (B)(6) 2025=32 IU/L, SAME PATIENT REDRAWN AND REPEATED WITH SID (B)(6) ON (B)(6) 2025=20 IU/L /REPEATED ON (B)(6) 2025=19.41 IU/L, THE SAME PATIENT REDRAWN AND REPEATED WITH SID (B)(6) ON (B)(6) 2025 = 23 IU/L /REPEATED ON (B)(6) 2025=3.84, 3.99, 3.63, 4.45, 3.73, 3.84, 6.46, 6.73, 5.84, 5.46 AND 5.8 IU/L (< OR =5.0 IU/L=NEGATIVE).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I B-HCG RESULTS ON MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: PATIENT 1 (B)(6) 2025: SID (B)(6): INITIAL= 50 IU/L (> 25.0 IU/L =POSITIVE) (B)(6) 2025: SID (B)(6): REDRAWN AND REPEATED = NEGATIVE (NO ACTUAL RESULT PROVIDED) (B)(6) 2025: REPEATED = < 2.3 IU/L (< OR =5.0 MIU/ML=NEGATIVE) PATIENT 2 (B)(6) 2025: SID (B)(6): INITIAL= 33 IU/L REPEAT FROM SERUM BANK SPECIMEN = NEGATIVE (NO ACTUAL RESULT PROVIDED) REDRAWN AND REPEATED SID (B)(6) = < 5.0 IU/L PATIENT 3 (B)(6) 2025 SID (B)(6): INITIAL= 47 IU/L REPEAT FROM SERUM BANK SPECIMEN = 47 IU/L (B)(6) 2025: SID (B)(6): REDRAWN AND REPEATED = < 5.0 IU/L REPEAT FROM SERUM BANK SPECIMEN SID (B)(6) = 39.75 IU/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I B-HCG RESULTS ON MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: PATIENT 1 ON (B)(6) 2025: SID (B)(6): INITIAL= 50 IU/L (> 25.0 IU/L =POSITIVE) ON (B)(6) 2025: SID (B)(6): REDRAWN AND REPEATED = NEGATIVE (NO ACTUAL RESULT PROVIDED) ON (B)(6) 2025: REPEATED = < 2.3 IU/L (< OR =5.0 MIU/ML=NEGATIVE). PATIENT 2 ON (B)(6) 2025: SID (B)(6): INITIAL= 33 IU/L REPEAT FROM SERUM BANK SPECIMEN = NEGATIVE (NO ACTUAL RESULT PROVIDED) REDRAWN AND REPEATED SID (B)(6) = < 5.0 IU/L. PATIENT 3 ON (B)(6) 2025 SID (B)(6): INITIAL= 47 IU/L REPEAT FROM SERUM BANK SPECIMEN = 47 IU/L ON (B)(6) 2025: SID (B)(6): REDRAWN AND REPEATED = < 5.0 IU/L REPEAT FROM SERUM BANK SPECIMEN SID (B)(6) = 39.75 IU/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11284 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I TOTAL BHCG 200T, 07P51-20, 69246UD00| ALNTY I TOTAL BHCG 200T, 07P51-20, 69246UD00| ALNTY I TOTAL BHCG 200T, 07P51-20, 69246UD00| ALNTY I TOTAL BHCG 200T, 07P51-20, 70286UD00| ALNTY I TOTAL BHCG 200T, 07P51-20, 70286UD00| ALNTY I TOTAL BHCG 200T, 07P51-20, 70286UD00