BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5797033 · Received July 14, 2016

    Report

    Report Number
    3007981285-2016-90384
    Event Type
    Injury
    Date Received
    July 14, 2016
    Date of Event
    June 11, 2016
    Report Date
    June 21, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 RECEIVED MULTIPLE, INTERMITTENT OCCLUSION ALARMS. THE CUSTOMER'S BLOOD GLUCOSE (BG) RANGED FROM 243-599 MG/DL. INSULIN INJECTIONS OR A BOLUS VIA THE PUMP WERE USED TO ADDRESS THE HIGH BG LEVELS. AS THE OCCLUSION ALARMS HAD OCCURRED IN THE PAST, TANDEM TECHNICAL SUPPORT WAS UNABLE TO PERFORM A SYSTEM CHECK TO DETERMINE A POSSIBLE CAUSE OF THE OCCLUSIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE REPLACEMENT PUMP HAD BEEN WORKING "FINE" AND THERE HAD BEEN NO FURTHER OCCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450338 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other