BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5191739 · Received October 30, 2015

    Report

    Report Number
    3007981285-2015-57291
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    October 10, 2015
    Report Date
    October 10, 2015
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED AND THE PUMP STOPPED ALL INSULIN DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS REPORTED TO BE 130 MG/DL. THERE WAS NO IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. IT WAS INDICATED THAT AN INJECTION WOULD BE TAKEN VIA AN INSULIN PEN TO ENSURE THAT INSULIN DELIVERY IS NOT INTERRUPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721931 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR