BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-CARE GLUCOMETER W/DEVICE KIT

    MDR report key: 20159840 · Received September 5, 2024

    Report

    Report Number
    MW5159266
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Report Date
    September 3, 2024
    Manufacturer
    HUDSON SCIENTIFIC, LLC
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PRESCRIBER STATED THAT THEY WERE INITIATING A NEW PA BECAUSE THE LAST GLUCOMETER BROKE. THEY WENT AFK AFTER THIS MESSAGE. NO ADDITIONAL INFORMATION REPORTED OR AVAILABLE REGARDING THIS EVENT. PAE REPORTED BY HCP, WHO DOES NOT CONSENT TO FOLLOW UP. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536380 D-CARE GLUCOMETER W/DEVICE KIT SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW HUDSON SCIENTIFIC, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown