BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQURE SYSTEM

    MDR report key: 16929025 · Received May 15, 2023

    Report

    Report Number
    3002807968-2023-00020
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Date of Event
    April 20, 2023
    Report Date
    July 18, 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

    AQURE WAS WORKING ACCORDING TO SPECIFICATION. THE CONNECTED DEVICE (LUMIRADX) WAS NOT CONFIGURED ACCORDING TO INSTRUCTIONS WHICH STATES THAT THE THIRD-PARTY-DEVICE(LUMIRADX) MUST BE CONFIGURED TO USE DOT(.) AS DECIMAL SYMBOL.. THE CONNECTED DEVICE WAS CONFIGURED TO USE COMMA(,) AS DECIMAL SYMBOL.

    Additional Manufacturer Narrative · 0

    RADIOMETER MEDICAL APS HAS RECEIVED CONFIRMATION THAT THE ISSUE WAS DISCOVERED BY A LUMIRADX REPRESENTATIVE AND THE CUSTOMER IN A TEST SETUP, NOT IN A CLINICAL SITUATION. THE RISK HAS BEEN RE-ASSESSED IN AND THE COMPLAINT IS NO LONGER CONSIDERED REPORTABLE.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINT, THE CUSTOMER IS FACING AN ISSUE ON AQURE (VERSION 2.6.1) WHEN RECEIVING PARAMETER CRP FROM LUMIRADX(THIRD-PARTY-DEVICE). WHEN LUMIRADX SENDS <5,0 TO AQURE, THE AQURE SYSTEM SHOWS 50 MG/L. ANOTHER EXAMPLE SHOWS A MEASUREMENT OF 33,4 MG/L WHERE AQURE SHOWS 334 MG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357757 AQURE SYSTEM AQURE SYSTEM OUG RADIOMETER MEDICAL APS 933-599 05700699335999

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown