BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 9284902 · Received November 6, 2019

    Report

    Report Number
    3013756811-2019-77373
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    October 24, 2019
    Report Date
    November 6, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TANDEM QUALITY ENGINEER EVALUATED PUMP DATA AND CONCLUDED THE FOLLOWING: A REVIEW OF THE LOG INDICATES THAT THE LOWEST BG READING ON 10/24/2019 WAS 55 MG/DL. THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. BLOOD GLUCOSE (BG) OF 55 MG/DL WAS RECORDED BY CONTINUOUS GLUCOSE MONITOR (CGM) AT 4:46:32 ON 10/24/2019 CGM ALERT 1 (CGM LOW ALERT) ENUNCIATED. ON 10/23/2019 AND 10/24/2019, 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE (BG) OF 50 MG/DL; CAUSE WAS UNKNOWN. FOOD WAS CONSUMED TO TREAT BG LEVEL. RECOMMENDATION WAS MADE TO CONSULT WITH HEALTHCARE PROVIDER REGARDING DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081926 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 39 YR Other