BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINIQ AMS

    MDR report key: 21619898 · Received March 17, 2025

    Report

    Report Number
    3004032053-2025-00007
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    March 5, 2025
    Report Date
    April 9, 2025
    Manufacturer
    ABBOTT SRL
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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

    THE COMPLAINT INVESTIGATION ON THE ALINIQ AMS SOFTWARE INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, AND LABELING REVIEW. THE COMPLAINT INVESTIGATION PERFORMED BY THE ALINIQ AMS TECHNICAL GROUP THE RESULTS FOR THE HIL (HEMOLYSIS, ICTERUS, LIPEMIA) INDEX AND LIVER FUNCTION TESTS (LFT) WERE PROCESSED CORRECTLY. HOWEVER, WHEN AN EC (ELECTROLYTE CONCENTRATION) TEST WAS ADDED, THE ORIGINAL HIL INDEX FAILED TO FLAG THE POTASSIUM (K) LEVEL. THE ROOT CAUSE WAS IDENTIFIED AS A CLERICAL ERROR BY AN ABBOTT REPRESENTATIVE. A REVIEW OF LABELING AND HISTORICAL DATA WAS DONE, AND BOTH WERE ADEQUATE, WITH NO INCREASE IN COMPLAINT ACTIVITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF ALINIQ AMS MIDDLEWARE, VERSION 3.02, WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED ONE HEMOLYZED SPECIMEN SID (B)(6) WITH H INDICES 2.4 AND POTASSIUM 8.1 DID NOT HOLD THE RESULTS ON AMS ANIQ SOFTWARE GENERATED FROM ALINITY C PROCESSING MODULE. THE CUSTOMER EXPECTED THAT THE HEMOLYZED SPECIMEN SUPPOSED BE HOLD IF HIL INDICES WITH RULE OF IF H=0.969 AND K>=3.4 THEN HOLD K(POTASSIUM) AS !H. THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED SOFTWARE UPGRADE 3.02 ON 05FEB2025 DURING THAT TIME HIL THRESHOLD OF THE RULE T_INDEX2OF3_NEW CHANGED TO 4.999 FROM 0 THAT CAUSE THAT HEMOLYZED SPECIMEN SID (B)(6) DID NOT HOLD THE RESULTS. THERE WAS NO DISCREPANT PATIENT RESULTS REPORTED OUT OF THE LABORATORY. THE ABBOTT FSR CORRECTED HIL THRESHOLD TO 0 FROM 4.999 AND VERIFIED BY RUNNING SID (B)(6) TO CONFIRMED HIL RULE WORKING PROPERLY. NO IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED ONE HEMOLYZED SPECIMEN SID (B)(6) WITH H INDICES 2.4 AND POTASSIUM 8.1 DID NOT HOLD THE RESULTS ON AMS ANIQ SOFTWARE GENERATED FROM ALINITY C PROCESSING MODULE. THE CUSTOMER EXPECTED THAT THE HEMOLYZED SPECIMEN SUPPOSED BE HOLD IF HIL INDICES WITH RULE OF IF H=0.969 AND K>=3.4 THEN HOLD K(POTASSIUM) AS !H. THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED SOFTWARE UPGRADE 3.02 ON (B)(6) 2025 DURING THAT TIME HIL THRESHOLD OF THE RULE T_INDEX2OF3_NEW CHANGED TO 4.999 FROM 0 THAT CAUSE THAT HEMOLYZED SPECIMEN SID (B)(6) DID NOT HOLD THE RESULTS. THERE WAS NO DISCREPANT PATIENT RESULTS REPORTED OUT OF THE LABORATORY. THE ABBOTT FSR CORRECTED HIL THRESHOLD TO 0 FROM 4.999 AND VERIFIED BY RUNNING SID (B)(6) TO CONFIRMED HIL RULE WORKING PROPERLY. NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210074 ALINIQ AMS CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT SRL OCN00481

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown