BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQURE

    MDR report key: 15309348 · Received August 29, 2022

    Report

    Report Number
    3002807968-2022-00031
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    May 19, 2022
    Report Date
    March 23, 2023
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    OUG
    UDI-DI
    05700699335999
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED.

    Additional Manufacturer Narrative · 0

    THE FINAL RADIOMETER INVESTIGATION HAS NOT BEEN ABLE TO FIGURE OUT , WHERE THE PROBLEM OCCURS, THE DEVICE SIDE OR THE AQURE SIDE, BECAUSE NO LOGS OR SCREENSHOT HAVE BEEN RECEIVED AND THE CUSTOMER HAS DISABLED THE FUNCTION WITH THE MPI QUERY (MASTER PATIENT INDEX). HOWEVER, AN UPGRADE TO AQURE VERSION 2.6.0 HAS BEEN MADE AND IT IS NOW WORKING AS EXPECTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D4: US UDI NUMBER ADDED.

    Additional Manufacturer Narrative · 0

    THERE ARE CURRENTLY NO USERS IN USA USING THE LUMIRADX CONNECTED TO AQURE, THUS THERE IS NO RISK FOR PATIENT MIX-UP TO OCCUR IN THE USA. A RECALL (915-424) HAS BEEN INITIATED IN ORDER TO REMOVE THE AFFECTED LUMIRADX DRIVER FROM ALL AQURE INSTALLATIONS IN THE USA IN ORDER TO PREVENT THE ERROR TO OCCUR IN THE FUTURE IF ANY AQURE CUSTOMERS BEGIN USING AQURE TOGETHER WITH LUMIRADX.

    Additional Manufacturer Narrative · 0

    RADIOMETER INVESTIGATION OF RECEIVED DATA LOGS HAS IDENTIFIED THAT THE INCIDENT OCCURRED DUE TO A SOFTWARE ERROR IN THE DRIVER CONNECTED TO THE LUMIRADX DEVICE (NON RADIOMETER DEVICE) WHICH WAS KEEPING THE MPI QUERY RESPONSE MESSAGES IN QUEUE. THIS CAN CAUSE THIS RESPONSE MESSAGE FAIL TO DELIVER TO THE DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER COMPLAINS ABOUT A PROBLEM WITH AQURE. ACCORDING TO THE COMPLAINT THE CUSTOMER MADE SOME TESTS BASED ON A PROBLEM THEY HAVE WITH A NOT RADIOMETER DEVICE (LUMIRADX). ONCE BY SCANNING A PATIENT TEST ID THE CUSTOMER RECEIVED INFORMATION FROM ANOTHER PATIENT TEST ID. SCENARIO OUTLINED: A) QUERY FROM ANALYZER FOR PATIENT 1234 B) QUERY FAILS C) QUERY FOR PATIENT ABCD D) ANALYZER RECEIVES INFORMATION FOR PATIENT 1234 IMMEDIATELY AFTER THE INCIDENT THE QUERY FUNCTIONALITY WAS DISABLED, HENCE PREVENTING FURTHER INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2100740 AQURE AQURE OUG RADIOMETER MEDICAL APS 933-599 05700699335999

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown