BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 5834106 · Received July 29, 2016

    Report

    Report Number
    3007981285-2016-93379
    Event Type
    Injury
    Date Received
    July 29, 2016
    Date of Event
    July 8, 2016
    Report Date
    July 9, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED 7/19/2016 THAT THE MALFUNCTION ALARM OCCURRED AGAIN MULTIPLE TIMES. THE PUMP STOPPED ALL INSULIN DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE (BG) WAS IMPACTED 350 (MG/DL). THE CUSTOMER TOOK A MANUAL INJECTION AND DRANK WATER. IT WAS INDICATED THAT THE CUSTOMER WOULD USE MANUAL INJECTIONS AS ALTERNATE INSULIN THERAPY UNTIL THE REPLACEMENT PUMP WAS RECEIVED. 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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN COMPLETED AND THE REPORTED ISSUE WAS CONFIRMED. IN ADDITION, A DIFFERENT ISSUE WAS ALSO FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED AND THE PUMP STOPPED ALL INSULIN DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 170 (MG/DL). THE CUSTOMER TOOK A MANUAL INJECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE INTERMITTENT MALFUNCTION ALARMS OCCURRED AND THE PUMP STOPPED ALL INSULIN DELIVERY. SUBSEQUENTLY, THE PUMP WAS NOTED TO BE UNRESPONSIVE. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS IMPACTED, ELEVATING FROM 170-350 (MG/DL). THE CUSTOMER ADDRESSED THEIR BG BY TAKING MANUAL INJECTIONS AND DRINKING WATER. IT WAS INDICATED THAT THE CUSTOMER WAS USING MANUAL INJECTIONS FOR ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486665 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other