BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6170821 · Received December 13, 2016

    Report

    Report Number
    3007981285-2016-24711
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 12, 2016
    Report Date
    November 29, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD BEEN EXPERIENCING DIFFICULTY CHARGING THE PUMP WITH THE USB CABLE. IT WAS CONFIRMED THAT THE PUMP WAS ABLE TO BE CHARGED WITH A DIFFERENT USB CABLE. IN ADDITION, CUSTOMER RECEIVED MULTIPLE CARTRIDGE ALARMS (CARTRIDGE ALARM 19) WITH MULTIPLE CARTRIDGES DURING THE LOAD PROCESS. CUSTOMER REPORTED BLOOD GLUCOSE (BG) LEVEL WAS 257 (MG/DL). IT WAS CONFIRMED THE CUSTOMER WAS ABLE TO RELOAD A CARTRIDGE AND DELIVER A BOLUS TO ADDRESS BG LEVEL. REPORTEDLY THE CUSTOMER HAS MANUAL INJECTIONS AS ALTERNATE INSULIN THERAPY UNTIL THE REPLACEMENT PUMP IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823072 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other