BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3950770 · Received June 9, 2014

    Report

    Report Number
    3007981285-2014-01033
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 10, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVALUATION. ATTEMPTS WERE MADE TO OBTAIN ALL AVAILABLE INFORMATION. SHOULD NEW INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING CUSTOMER HAD STOPPED INSULIN DELIVERY TO TAKE A SHOWER, AND RECEIVED AN ALARM WHEN ATTEMPTING TO RESUME INSULIN. INSULIN DELIVERY WAS INTERRUPTED FOR APPROXIMATELY 15 MINUTES. THERE WAS NO REPORTED IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334444 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR