BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 7132593 · Received December 19, 2017

    Report

    Report Number
    3007981285-2017-39738
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    December 14, 2017
    Report Date
    December 19, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE USER GUIDE: ALWAYS ENSURE THAT THERE ARE NO AIR BUBBLES IN THE TUBING WHEN FILLING. PER THE CARTRIDGE INSTRUCTIONS FOR USE: MAKE SURE THAT INSULIN IS AT ROOM TEMPERATURE BEFORE FILLING CARTRIDGE. 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'S BLOOD GLUCOSE (BG) LEVEL RANGED FROM 200-343 MG/DL AND INSULIN INJECTIONS WERE ADMINISTERED TO ADDRESS THE BG LEVEL. THE CAUSE OF THE BG LEVEL WAS NOT KNOWN. DURING TROUBLESHOOTING, WHITE SPOTS ON THE TUBING WERE FOUND. THERE WERE NO AIR BUBBLES. REPORTEDLY, THE CUSTOMER USED COLD INSULIN TO FILL THE CARTRIDGE AND DID NOT REMOVE THE AIR FROM THE CARTRIDGE. THE CUSTOMER CHANGED THE PUMP SUPPLIES AND RESUMED INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911069 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR