BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 8294217 · Received January 31, 2019

    Report

    Report Number
    3013756811-2019-03535
    Event Type
    Injury
    Date Received
    January 31, 2019
    Date of Event
    January 6, 2019
    Report Date
    January 31, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE USER GUIDE INCOMPLETE BOLUS ALERT: YOU STARTED A BOLUS REQUEST BUT DID NOT COMPLETE THE REQUEST WITHIN 90 SECONDS. TAP CLOSE. THE BOLUS SCREEN WILL APPEAR. CONTINUE WITH YOUR BOLUS REQUEST. TAP BACK IF YOU DO NOT WANT TO CONTINUE YOUR BOLUS REQUEST. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE (BG) WAS 202-396 MG/DL AND AN INSULIN PEN WAS USED TO LOWER BG TO 141 MG/DL. CUSTOMER'S HOME NURSE ASSISTED THE CUSTOMER WITH CHANGING THE INFUSION SET SITE. CUSTOMER THOUGHT A FOOD BOLUS WAS DELIVERED AT BREAKFAST AND LUNCH; HOWEVER, AFTER CHECKING PUMP HISTORY, IT WAS FOUND THAT AN INCOMPLETE BOLUS ALERT OCCURRED DURING THOSE TIMES. UPON FOLLOW UP, CUSTOMER'S BG WAS 103 MG/DL AND WAS NOT EXPERIENCING ANY FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86542 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 65 YR Required Intervention INFUSION SET: AUTOSOFT 90, INSULIN: NOVOLOG