BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5549363 · Received April 5, 2016

    Report

    Report Number
    3007981285-2016-74100
    Event Type
    Injury
    Date Received
    April 5, 2016
    Date of Event
    March 11, 2016
    Report Date
    March 14, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 CHANGED THE SUPPLIES ON THE PUMP AFTER EACH OCCLUSION ALARM. THE CUSTOMER'S BLOOD GLUCOSE RANGED BETWEEN 180-480 MG/DL. AS THE OCCLUSIONS HAD OCCURRED IN THE PAST, TANDEM TECHNICAL SUPPORT WAS UNABLE TO TROUBLESHOOT TO DETERMINE A POSSIBLE CAUSE OF THE OCCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203689 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other INFUSION SET: INSET, INSULIN: HUMALOG