BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6116976 · Received November 21, 2016

    Report

    Report Number
    3007981285-2016-21361
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    October 26, 2016
    Report Date
    November 2, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE T:SLIM PUMP USER GUIDE INDICATES REPLACE THE CARTRIDGE EVERY 48 HOURS IF USING HUMALOG TANDEM¿S T:SLIM USER GUIDE DESCRIBES HOW TO REMOVE AIR FROM THE CARTRIDGE USING THE SYRINGE 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 EXPERIENCED BLOOD GLUCOSE (BG) LEVEL RANGE (240-309 MG/DL.)WITH KETONES PRESENT. THE CUSTOMER WOULD DELIVER MANUAL INJECTIONS AND BOLUS VIA THE PUMP TO STABILIZE BG LEVEL. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER REPORTED AIR GAPS IN THE TUBING. REPORTEDLY, THE CUSTOMER DID NOT REMOVE THE AIR WHEN LOADING THE CARTRIDGE AND HAD LAST CHANGED SUPPLIES 6 DAYS AGO. THE CUSTOMER WAS EDUCATED TO REMOVE AIR FROM THE CARTRIDGE AND THAT HUMALOG HAS BEEN TESTED UP TO 48 HOURS. THE CUSTOMER WAS ABLE TO LOAD A NEW CARTRIDGE AND RESUME INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768543 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other INFUSION SET: INSET, INSULIN: HUMALOG