BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15130170 · Received July 29, 2022

    Report

    Report Number
    3013756811-2022-79328
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    July 8, 2022
    Report Date
    July 9, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 AND EVALUATION IS PERFORMED. PER TANDEM USER GUIDE: AVOID SUBMERGING YOUR PUMP IN FLUID BEYOND A DEPTH OF 3 FEET (0.91 M) OR FOR MORE THAN 30 MINUTES (IPX7 RATING). IF YOUR PUMP HAS BEEN EXPOSED TO FLUID BEYOND THESE LIMITS, CHECK FOR ANY SIGNS OF FLUID ENTRY. IF THERE ARE SIGNS OF FLUID ENTRY, DISCONTINUE USE OF THE PUMP AND CONTACT CUSTOMER TECHNICAL SUPPORT. PER TANDEM USER GUIDE: DO NOT USE YOUR PUMP IF YOU THINK IT MIGHT BE DAMAGED DUE TO DROPPING IT OR HITTING IT AGAINST A HARD SURFACE. CHECK THAT THE PUMP IS WORKING PROPERLY BY PLUGGING A POWER SOURCE INTO THE USB PORT AND CONFIRMING THAT THE DISPLAY TURNS ON, YOU HEAR AUDIBLE BEEPS, FEEL THE PUMP VIBRATE, AND SEE THE GREEN LED LIGHT BLINKING AROUND THE EDGE OF THE SCREEN ON/QUICK BOLUS BUTTON. IF YOU ARE UNSURE ABOUT POTENTIAL DAMAGE, DISCONTINUE USE OF THE PUMP AND CONTACT CUSTOMER TECHNICAL SUPPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS INTERMITTENTLY UNRESPONSIVE. DURING TROUBLESHOOTING, THE ISSUE WAS CONFIRMED. REPORTEDLY, CUSTOMER DROPPED THE PUMP IN WATER. CUSTOMER'S BLOOD GLUCOSE WAS 190-300 MG/DL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD IN INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2281409 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male