BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5211594 · Received November 9, 2015

    Report

    Report Number
    3007981285-2015-57258
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 14, 2015
    Report Date
    October 14, 2015
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE TANDEM USER GUIDE INDICATES THAT WHILE THE INSULIN DURATION SETTING REFLECTS HOW LONG INSULIN FROM PREVIOUS BOLUSES LOWERS YOUR BLOOD GLUCOSE, THE INSULIN ON BOARD (IOB) FEATURE REFLECTS HOW MUCH INSULIN IS REMAINING IN YOUR BODY FROM PREVIOUS BOLUSES. THE PRODUCT HAS NOT BEEN 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 THE CUSTOMER WANTED TO KNOW HOW TO STOP A BOLUS THAT WAS PROGRAMMED INTO THE PUMP AS IT WAS NO LONGER REQUIRED. TANDEM TECHNICAL SUPPORT REVIEWED THE PUMP SETTINGS WITH THE CUSTOMER AND DISCOVERED THAT THE CUSTOMER WANTED TO STOP THE INSULIN ON BOARD (IOB). HOWEVER, IT WAS EXPLAINED TO THE CUSTOMER THAT THE IOB REPRESENTED ACTIVE INSULIN THAT HAD ALREADY BEEN DELIVERED TO THE BODY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER INDICATED THAT GLUCOSE WILL BE CONSUMED TO COVER THE EXTRA INSULIN TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740653 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR