BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3935477 · Received June 23, 2014

    Report

    Report Number
    3007981285-2014-01723
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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 REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION REGARDING AIR BUBBLES IN THE PATIENT LINE (PIGTAIL). CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366805 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M002407

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other