BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3893714 · Received June 10, 2014

    Report

    Report Number
    3007981285-2014-01089
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REC'D INFO REGARDING A SEPARATION BETWEEN THE PT LINE (PIGTAIL) AND THE LUER LOCK. CUSTOMER HAD DKA AND HAS EXPERIENCED HIGH BLOOD GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340264 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other INFUSION SET: CONTACT DETACH