BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 9820190 · Received March 11, 2020

    Report

    Report Number
    3013756811-2020-22631
    Event Type
    Injury
    Date Received
    March 11, 2020
    Date of Event
    February 19, 2020
    Report Date
    March 11, 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: BLOOD GLUCOSE (BG) VALUES FROM 42-49 MG/DL WERE RECORDED BY CONTINUOUS GLUCOSE MONITOR (CGM) FROM 8:09:05 PM TO 8:59:05 PM ON 2/19/2020. CGM ALERT 1 (CGM LOW ALERT) ENUNCIATED AT 8:04:05 PM. ON 2/19/2020, AT 4:31:23 PM, USER MADE A BOLUS REQUEST WITHOUT ENTERING CURRENT BG. MAKING BOLUS REQUESTS WITHOUT ENTERING CURRENT BG COULD LEAD TO A LOW BG EVENT. ON 2/19/2020, AT 6:05:25 PM, USER MADE A BOLUS REQUEST WITHOUT ENTERING CURRENT BG AND WHILE STILL HAVING INSULIN ON BOARD (IOB). MAKING BOLUS REQUESTS WITHOUT ENTERING CURRENT BG AND WHILE STILL HAVING IOB 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) OF 43 MG/DL; CAUSE WAS UNKNOWN. HONEY WAS CONSUMED TO TREAT BG LEVEL. ALTHOUGH REQUESTED, THE CUSTOMER DECLINED TROUBLESHOOTING AND DECLINED TO PROVIDE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280818 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