BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 10025609 · Received May 5, 2020

    Report

    Report Number
    3013756811-2020-43629
    Event Type
    Injury
    Date Received
    May 5, 2020
    Date of Event
    April 15, 2020
    Report Date
    May 5, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TANDEM QUALITY ENGINEER EVALUATED PUMP DATA AND CONCLUDED THE FOLLOWING: BLOOD GLUCOSE (BG) VALUES FROM ¿LOW¿ (BELOW 40 MG/DL) TO 52 MG/DL WERE RECORDED BY CONTINUOUS GLUCOSE MONITOR (CGM) FROM 2:28:35 AM TO 3:23:35 AM ON 4/15/2020. CGM ALERT 1 (CGM LOW ALERT) ENUNCIATED AT 2:28:35 AM. ON 4/14/2020 AT 8:09:06 PM, AND 4/15/2020 AT 1:02:07 AM, 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

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL OF 42 MG/DL. BG CAUSE WAS NOT KNOWN. CUSTOMER RECEIVED ASSISTANCE FROM PARAMEDIC AND CONSUMED JUICE AND CRACKERS TO ADDRESS BG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488891 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 55 YR Required Intervention