BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCH

    MDR report key: 16690535 · Received April 5, 2023

    Report

    Report Number
    MW5116394
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    April 3, 2023
    Report Date
    April 3, 2023
    Manufacturer
    LIFESCAN SCOTLAND LTD.
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE PATIENT HAD PREVIOUSLY USED A ONETOUCH DEVICE AND THE PATIENT REPORTED THAT THE PRODUCT WAS NOT ACCURATE. PAE REPORTED BY PATIENCE S AT HCP, (B)(6), APRN'S OFFICE. PATIENCE DID CONSENT TO FOLLOW UP; (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519711 ONETOUCH GLUCOSE OXIDASE, GLUCOSE CGA LIFESCAN SCOTLAND LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male