BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 9820910 · Received March 11, 2020

    Report

    Report Number
    3013756811-2020-26258
    Event Type
    Injury
    Date Received
    March 11, 2020
    Date of Event
    February 23, 2020
    Report Date
    March 11, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007325
    PMA / PMN Number
    DEN180058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 50 MG/DL WERE RECORDED BY CONTINUOUS GLUCOSE MONITOR (CGM) FROM 10:53:09 AM TO 11:53:09 AM ON 2/23/2020. CGM ALERT 1 (CGM LOW ALERT) ENUNCIATED AT 10:53:09 AM ON 2/23/2020. A TUBING FILL OF SIZE 16.0 UNITS WAS OBSERVED ON 2/23/2020 AT 9:05:01 AM. IF USER DID NOT DISCONNECT DURING THE ¿FILL TUBING¿ STEP OF THE CARTRIDGE CHANGE SEQUENCE, INSULIN WOULD BE DELIVERED, AND THIS COULD CAUSE BG LEVELS TO DROP. ON 2/23/2020, AT 7:45:23 AM, USER MADE A BOLUS REQUEST 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL; BG VALUE WAS NOT PROVIDED AND CAUSE WAS UNKNOWN. PARAMEDICS WERE CALLED AND ADMINISTERED INTRAVENOUS FLUIDS, ORANGE JUICE, LEMONADE, AND CRACKERS TO ADDRESS BG LEVEL. RECOMMENDATION WAS MADE TO DISCUSS DIABETES MANAGEMENT WITH A HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279972 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007325

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention