BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6777432 · Received August 9, 2017

    Report

    Report Number
    3007981285-2017-22077
    Event Type
    Injury
    Date Received
    August 9, 2017
    Date of Event
    July 18, 2017
    Report Date
    August 9, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED MULTIPLE OCCLUSION ALARMS OCCURRED. AN INFUSION SET CHANGE WAS PERFORMED AND AN ADDITIONAL OCCLUSION ALARM OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVELS RANGED BETWEEN 153-247 MG/DL. A CORRECTION BOLUS WAS TO BE ADMINISTERED TO ADDRESS THE BG LEVEL OF 247 MG/DL. A SYSTEM CHECK WAS PERFORMED AND THE PUMP PERFORMED AS INTENDED. DURING A FOLLOW-UP, IT WAS REPORTED AN INFUSION SET CHANGE WAS PERFORMED AND THE OCCLUSION ALARMS CONTINUED TO OCCUR. A CARTRIDGE CHANGE WAS PERFORMED AND THE CUSTOMER SUCCESSFULLY DELIVERED A CORRECTION BOLUS. REPORTEDLY, THE CUSTOMER WEARS THEIR PUMP AGAINST THEIR SKIN, TANDEM TECHNICAL SUPPORT ADVISED THE CUSTOMER TO PROTECT THE CARTRIDGES FROM PROLONGED EXPOSED TO OILS OR LOTIONS THAT MAY CAUSE CARTRIDGE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556776 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other INFUSION SET: CLEO, INSULIN: HUMALOG