BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SOFT XC

    MDR report key: 14633205 · Received June 7, 2022

    Report

    Report Number
    MW5110194
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    May 28, 2022
    Report Date
    June 5, 2022
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    USING TANDEM T:SLIM AUTO SOFT XC EXPERIENCED DIABETIC KETO ACIDOSIS DKA DUE TO CANNULA BEING INSERTED AND CRIMPED OR BENT PREVENTING PROPER INSULIN DELIVERY. THIS OCCURRED AGAIN ON (B)(6) 2022. THIS IS THE SECOND TIME IN TWO WEEKS SINCE SWITCHING FROM MEDTRONIC INSERTION DEVICES THAT NEVER CAUSED THIS ISSUE. TANDEM AUTO SOFT XC. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318730 AUTO SOFT XC SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL A/S
    318731 AUTO SOFT XC SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Other TANDEM T:SLIM X2