BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6047576 · Received October 21, 2016

    Report

    Report Number
    3007981285-2016-15353
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    October 1, 2016
    Report Date
    October 1, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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 RECEIVED AN INACCURATE FILL ESTIMATE. REPORTEDLY, THE CARTRIDGE WAS FILLED WITH 260 UNITS OF INSULIN. IN ADDITION, IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE OCCLUSION ALARMS. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, AND INDICATED THAT THE SUPPLIES WOULD BE CHANGED UPON RETURNING HOME. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 113-125 MG/DL. MULTIPLE ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO OBTAIN IF THE REPORTED EVENTS HAD BEEN RESOLVED; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699032 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR