BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 11440056 · Received March 8, 2021

    Report

    Report Number
    3013756811-2021-30912
    Event Type
    Malfunction
    Date Received
    March 8, 2021
    Date of Event
    February 14, 2021
    Report Date
    February 14, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM¿S PUMP USER GUIDE: YOU SHOULD AVOID ACTIVITIES WHICH COULD EXPOSE YOUR PUMP TO TEMPERATURES BELOW 41ºF (5ºC) OR ABOVE 98.6ºF (37ºC), AS INSULIN CAN FREEZE AT LOW TEMPERATURES OR DEGRADE AT HIGH TEMPERATURES. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. THE CAUSE WAS UNKNOWN; HOWEVER, CUSTOMER ADMITTED TO EXPOSING PUMP TO EXTREME COLD TEMPERATURES. CUSTOMER¿S BLOOD GLUCOSE WAS BETWEEN 121-149 MG/DL. THE CUSTOMER HAD RESOLVED THE ISSUE AND RESUMED INSULIN DELIVERY PRIOR TO CONTACTING TANDEM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329788 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR