BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3862757 · Received May 27, 2014

    Report

    Report Number
    3007981285-2014-00817
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 27, 2014
    Report Date
    April 28, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO TRY AND RETRIEVE FURTHER EVENT INFORMATION WITH NO CUSTOMER RESPONSE. SHOULD NEW INFORMATION BECOME AVAILABLE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING PATIENT WAS HOSPITALIZED DUE TO DKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311802 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R