BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINIQ AMS

    MDR report key: 22201269 · Received June 13, 2025

    Report

    Report Number
    3004032053-2025-00016
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    May 19, 2025
    Report Date
    July 24, 2025
    Manufacturer
    ABBOTT SRL
    Product Code
    JQP
    UDI-DI
    00380740202736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, A SEARCH FOR SIMILAR COMPLAINTS, A TICKET TRENDING REVIEW, A DEVICE HISTORY RECORD REVIEW, AND A LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE INVESTIGATION FOUND THAT THE ISSUE OCCURRED BECAUSE A PARAMETER IN THE SAMPLE WAS EITHER NOT PROPERLY IDENTIFIED OR NOT MEASURED, CAUSING SOME MEASUREMENTS TO GO UNRECOGNIZED. THE CUSTOMER USES A CUSTOMIZED SET OF AMS RULES DESIGNED FOR HEMATOLOGY. THE RULES WERE CONFIGURED TO REMOVE THE ¿X¿ FLAG AND EVALUATE THE NUMERIC VALUE. IN THE EXAMPLES PROVIDED, THE NUMERIC VALUES DID NOT MEET ANY CONDITIONS THAT WOULD REQUIRE THE RESULT TO BE HELD. SINCE NO RULE CONDITIONS WERE MET, THE SYSTEM PROCEEDED WITH AUTOMATIC VALIDATION. A REVIEW OF TRACKING AND TRENDING FOR THE ALINIQ AMS SOFTWARE DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. THE CURRENT TICKET IS THE SOLE COMPLAINT FOR THE REPORTED ISSUE. THE DEVICE HISTORY RECORD WAS REVIEWED AND DID NOT IDENTIFY ANY NON-CONFORMANCE'S OR POTENTIAL NON-CONFORMANCE'S RELATED TO THE ISSUE DESCRIBED IN THE CURRENT COMPLAINT. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINIQ AMS SOFTWARE, VERSION 3.02.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE ALINIQ AMS SOFTWARE AUTO-RELEASED INVALID WBC AND DIFFERENTIAL RESULTS, WHICH WERE GENERATED BY THE ALINITY HQ ANALYZER, FOR A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6): SEQ# (B)(4), (B)(6) 2025; WBC = 11.4 X 10E9/L (INVALIDATED WITH X); NEU = 7.07 X 10E9/L (INVALIDATED WITH X); NEU% = 62.3% (INVALIDATED WITH X); LYM = 2.91 X 10E9/L (INVALIDATED WITH X); LYM% = 25.6% (INVALIDATED WITH X); MONO = 1.25 X 10E9/L (INVALIDATED WITH X); MONO% = 11.0 % (INVALIDATED WITH X); EOS = 0.0 X 10E9/L (INVALIDATED WITH X); EOS% = 0.0% (INVALIDATED WITH X); BASO = 0.122 X 10E9/L (INVALIDATED WITH X); BASO% = 1.07% (INVALIDATED WITH X); IG = 0.001 X 10E9/L (INVALIDATED WITH X); IG% = 0.011 % (INVALIDATED WITH X); NRBC = 0.00 X 10E9/L (INVALIDATED WITH X); NR/W = 0.00 (INVALIDATED WITH X); RBC = 2.51 X 10E12/L (INVALIDATED WITH X); FLAG: VAR LYM FLAG; THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE ALINIQ AMS SOFTWARE AUTO-RELEASED INVALID WBC AND DIFFERENTIAL RESULTS, WHICH WERE GENERATED BY THE ALINITY HQ ANALYZER, FOR A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6): SEQ# 207400 (HQ01161) (B)(6) 2025, WBC = 11.4 X 10E9/L (INVALIDATED WITH X) NEU = 7.07 X 10E9/L (INVALIDATED WITH X) NEU% = 62.3% (INVALIDATED WITH X) LYM = 2.91 X 10E9/L (INVALIDATED WITH X) LYM% = 25.6% (INVALIDATED WITH X) MONO = 1.25 X 10E9/L (INVALIDATED WITH X) MONO% = 11.0 % (INVALIDATED WITH X) EOS = 0.0 X 10E9/L (INVALIDATED WITH X) EOS% = 0.0% (INVALIDATED WITH X) BASO = 0.122 X 10E9/L (INVALIDATED WITH X) BASO% = 1.07% (INVALIDATED WITH X) IG = 0.001 X 10E9/L (INVALIDATED WITH X) IG% = 0.011 % (INVALIDATED WITH X) NRBC = 0.00 X 10E9/L (INVALIDATED WITH X) NR/W = 0.00 (INVALIDATED WITH X) RBC = 2.51 X 10E12/L (INVALIDATED WITH X) FLAG: VAR LYM FLAG, THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353935 ALINIQ AMS CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT SRL 00380740202736

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown