BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 9800433 · Received March 6, 2020

    Report

    Report Number
    3013756811-2020-25239
    Event Type
    Injury
    Date Received
    March 6, 2020
    Date of Event
    February 15, 2020
    Report Date
    March 6, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TANDEM QUALITY ENGINEER EVALUATED PUMP DATA AND CONCLUDED THE FOLLOWING: THE CONTINUOUS GLUCOSE MONITOR WAS NOT IN USE ON (B)(6) 2020. THE LOWEST BLOOD GLUCOSE (BG) ENTERED INTO THE PUMP BY THE USER WAS 193 MG/DL ON (B)(6) 2020. THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. ON (B)(6) 2020, USER MADE BOLUS REQUESTS WHILE STILL HAVING INSULIN ON BOARD (IOB). MAKING BOLUS REQUESTS WHILE STILL HAVING IOB COULD LEAD TO A LOW BG EVENT. ON (B)(6) 2020, USER MADE BOLUS REQUESTS WITHOUT ENTERING CURRENT BG. MAKING BOLUS REQUESTS WITHOUT ENTERING CURRENT BG COULD LEAD TO A LOW BG EVENT. THERE IS NO EVIDENCE THAT THE PUMP EXPERIENCED A MALFUNCTION OR FAILURE.

    Additional Manufacturer Narrative · 1

    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 EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL OF 36 MG/DL. CAUSE OF LOW BG WAS NOT KNOWN. REPORTEDLY, THE ISSUE MAY HAVE BEEN CAUSED BY PHYSICAL ACTIVITY OR POSSIBLY DELIVERING A BOLUS; HOWEVER THIS COULD NOT BE CONFIRMED. CUSTOMER CONSUMED JUICE AND EGG NOG TO ADDRESS BG. RECOMMENDATION WAS MADE TO CONSULT WITH A HEALTHCARE PROVIDER TO DISCUSS DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262320 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 61 YR Other