BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTO SOFT 90 23 INCH 9MM INFUSION SET

    MDR report key: 11343963 · Received February 17, 2021

    Report

    Report Number
    MW5099472
    Event Type
    Injury
    Date Received
    February 17, 2021
    Date of Event
    January 20, 2021
    Report Date
    February 15, 2021
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE QUALITY OF THE ADHESIVE ON THE AUTOSOFT 90 INFUSION SETS 9 MM 23 INCH HAS DETERIORATED OVER TIME TO MAKE THEM INEFFECTIVE. THEY ARE A VITAL PART TO THE HYBRID CLOSED LOOP PANCREAS SYSTEM BY TANDEM. THESE ARE DISTRIBUTED BY TANDEM DIABETES PRODUCED BY UNOMEDICAL A DENMARK COMPANY MADE IN MEXICO. IT SEEMS UNOMEDICAL HAS A MONOPOLY ON THE MARKET. THESE INFUSION SETS BY NOT ADHERING TO THE BODY AFTER ALL OTHER ADHESIVES AND TAPES ARE USED , CAUSE HIGH BLOOD SUGAR LEVELS CAUSING THE PUMP AND SENSOR DELIVERING MORE WASTED INSULIN CAUSING POTENTIAL MAJOR BODILY ISSUES. ATTEMPTS TO CONTACT UNOMEDICAL AND TANDEM DIABETES HAVE NOT RECEIVED RESPONSES. ALSO, RECENT NEEDLE ADHESIVE TO THE SET UPON CHANGING HAS RECENTLY BEEN OBSERVED. CAUSING A CHANGE IN INFUSION SETS. THE BOTTOM LINE IS WASTED OF INSULIN, INFUSION SETS HAVE TO BE INJECTED EACH TIME INTO THE BODY AND POTENTIAL MAJOR HEALTH ISSUES. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236250 AUTO SOFT 90 23 INCH 9MM INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL A/S 1002819 5314561

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Life Threatening| S