BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3830039 · Received May 1, 2014

    Report

    Report Number
    3007981285-2014-00475
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 4, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A FELLOW UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING CUSTOMER'S PUMP HA UNEXPECTEDLY SHUTDOWN ON MULTIPLE OCCASIONS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261812 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other