BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3893938 · Received June 12, 2014

    Report

    Report Number
    3007981285-2014-01111
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVAL. ATTEMPTS HAVE BEEN MADE TO OBTAIN ALL EVENT INFO. SHOULD NEW INFO BECOME AVAILABLE, A F/U MDR WILL BE SUBMITTED. PER THE T: SLIM INSULIN PUMP USER GUIDE, THE INCOMPLETE BOLUS ALERT OCCURS IF THE USER PROGRAMS A BOLUS BUT DOES NOT COMPLETE THE REQUEST WITHIN 90 SECONDS.

    Description of Event or Problem · 1

    RECEIVED INFO STATING CUSTOMER RECEIVED AN INCOMPLETE BOLUS ALERT. REPORTEDLY, THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348691 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other INFUSION SET: QUICK SET