BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINIQ AMS

    MDR report key: 16285085 · Received February 2, 2023

    Report

    Report Number
    3004032053-2023-00004
    Event Type
    Malfunction
    Date Received
    February 2, 2023
    Date of Event
    January 10, 2023
    Report Date
    March 17, 2023
    Manufacturer
    ABBOTT SRL
    Product Code
    JQP
    UDI-DI
    00380740189914
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INDICATED THAT THE ROOT CAUSE OF THE ISSUE WAS A USE ERROR IN SAMPLE MANAGEMENT PERFORMED BY THE CUSTOMER THAT RESULTED IN AN INCORRECT ASSIGNMENT OF THE DEMOGRAPHIC DETAILS OF A PATIENT TO ANOTHER ONE IN ALINIQ AMS. A BARCODED SID LABEL WAS RE-USED IN THE LABORATORY BEFORE A 7-DAYS¿ TIME FRAME PERIOD CONFIGURED IN ALINIQ AMS. AS A CONSEQUENCE OF THIS ACTION, THE ALINIQ AMS ASSOCIATED THE RESULTS RECEIVED FOR THE INSTRUMENT TO PATIENT ID (B)(6), WHICH WAS STILL PRESENT IN THE MIDDLEWARE DATABASE AND LINKED TO THIS SID (B)(6). CONVERSELY, THE LIS ASSOCIATED AND RELEASED THE RESULTS RECEIVED FROM ALINIQ AMS TO PATIENT ID (B)(6), ALSO ASSOCIATED TO SID (B)(6). SINCE THE CORRECT PATIENT DETAILS WERE IN THE LIS THAT MATCHED THE SID, THE RESULTS WERE REPORTED CORRECTLY. GIVEN THAT NO INCORRECT BEHAVIOR WAS IDENTIFIED IN ALINIQ AMS AND THE CORRECT PATIENT DETAILS AND RESULTS WERE EVENTUALLY REPORTED CORRECTLY IN THE LIS, NO CORRECTIONS HAVE BEEN TAKEN. NO RE-OCCURRENCE OF THE EVENTS HAVE OCCURRED. TRENDING REVIEW DETERMINED NO TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED WITH THE ALINIIQ SOFTWARE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A PATIENT PROCESSED ON (B)(6) 2023 WITH SID(B)(6) HAD DETAILS FROM A DIFFERENT PATIENT IN THE AMS. THE CORRECT PATIENT DETAILS WERE IN THE LIS THAT MATCHED THE SID THEREFORE THE RESULTS WERE REPORTED CORRECTLY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401493 ALINIQ AMS CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT SRL 03R89-48 NA 00380740189914

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown