BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6186366 · Received December 19, 2016

    Report

    Report Number
    3007981285-2016-26335
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    December 8, 2016
    Report Date
    December 8, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EMPTY CARTRIDGE ALARM OCCURRED WHEN THE CARTRIDGE HAD 0 UNITS AND THE CUSTOMER HAD TO REVERT TO MANUAL INJECTIONS. REPORTEDLY, THE USER'S BLOOD GLUCOSE (BG) LEVEL WAS 352 MG/DL. THE USER ADDRESSED BG LEVEL WITH A MANUAL INJECTION. TANDEM'S TECHNICAL SUPPORT CONFIRMED IN THE PUMP HISTORY THAT A LOW INSULIN ALERT OCCURRED PRIOR TO THE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838382 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other