BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4852561 · Received June 17, 2015

    Report

    Report Number
    3007981285-2015-35397
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    May 27, 2015
    Report Date
    May 27, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVAL. SHOULD NEW RELEVANT INFO BECOME AVAILABLE A SUPPLEMENTAL FORM WILL BE SUBMITTED. T:SLUM USER GUIDE INDICATES, THE CARTRIDGE IS INDICATED AS A RESERVOIR FOR THE DELIVERY OF RAPID-ACTING INSULIN, HUMALOG WAS TESTED FOR UP TO 48 HOURS OF USE AS LABELED. THE CARTRIDGE IS CONTRAINDICATED FOR USE WITH PRODUCTS OTHER THAN HUMALOG AND NOVOLOG.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS (382 MG/DL). CUSTOMER HAS BEEN ADJUSTING PUMP SETTINGS WITHOUT GUIDANCE FROM HER HEALTH CARE PROFESSIONAL. TROUBLESHOOTING WAS UNABLE TO BE PERFORMED BECAUSE CUSTOMER HAS ALREADY CHANGED OUT THE CARTRIDGE NAD INFUSION SET. FILL TUBING WAS PERFORMED WITH NEW CARTRIDGE AND INFUSION SET AND PUMP IS DELIVERING AS EXPECTED. CARTRIDGE AND INFUSION SET ARE CHANGED EVERY 3 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394557 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other INSULIN: HUMALOG.| INFUSION SET: INSET,