BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVEY SYSTEM

    MDR report key: 3934552 · Received June 27, 2014

    Report

    Report Number
    3007981285-2014-01848
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 31, 2014
    Report Date
    May 31, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING CUSTOMER RECEIVED AN ALTITUDE ALARM DURING BASAL DELIVERY. REPORTEDLY, THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS "A LITTLE HIGH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375744 TANDEM T:SLIM INSULIN DELIVEY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other