BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 18810458 · Received February 27, 2024

    Report

    Report Number
    MW5152170
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    February 25, 2024
    Report Date
    February 25, 2024
    Manufacturer
    LIFESCAN SCOTLAND LTD.
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT AND MEDICAL TEAM WERE UNABLE TO SET UP ONETOUCH ULTRA2 GLUCOSE MONITORING DEVICE TO MONITOR FOR HYPERGLYCEMIA / HYPOGLYCEMIA. THE LIFESCAN, INC TECHNICAL SUPPORT DOES NOT WORK ON WEEKENDS AND AFTER HOURS. WHEREAS DIABETES DOES NOT GO AWAY ON WEEKENDS. MULTIPLE TESTS DURING THE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297168 ONE TOUCH ULTRA2 METER GLUCOSE OXIDASE, GLUCOSE CGA LIFESCAN SCOTLAND LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Life Threatening