BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5521529 · Received March 23, 2016

    Report

    Report Number
    3007981285-2016-72960
    Event Type
    Injury
    Date Received
    March 23, 2016
    Date of Event
    February 26, 2016
    Report Date
    February 29, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 MULTIPLE INTERMITTENT OCCLUSION ALARMS. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 250-289 MG/DL AND REPORTEDLY, THE BG LEVEL WAS UNDER CONTROL AT THE TIME TANDEM CUSTOMER TECHNICAL SUPPORT (CTS) WAS CALLED. THE CUSTOMER INDICATED THAT THE TUBING WAS A POSSIBLE CAUSE OF ONE OCCLUSION; HOWEVER, AS THE SUPPLIES TO THE PUMP HAD BEEN CHANGED AND AS THE OCCLUSION ALARM WAS NOT OCCURRING AT THE TIME OF THE REPORT. CTS WAS UNABLE TO CONFIRM THE CAUSE OF THE OCCLUSIONS. THE CUSTOMER REVERTED TO USING A BACKUP PUMP TO MANAGE DIABETES UNTIL SUPPLIES ARE RESTOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176279 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 Other