BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3893966 · Received June 12, 2014

    Report

    Report Number
    3007981285-2014-01103
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE IS EXPECTED TO BE RETURNED; HOWEVER, THE CARTRIDGE HAS NOT YET BEEN RECEIVED. A F/U MDR WILL BE SUBMITTED IF THE PRODUCT IS RECEIVED.

    Description of Event or Problem · 1

    RECEIVED INFO STATING CUSTOMER RECEIVED MULTIPLE OCCLUSION ALARMS DURING BOLUS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED. REPORTEDLY, THE CARTRIDGE APPEARED TO BE CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348686 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628 M002623

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other