BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3911665 · Received May 28, 2014

    Report

    Report Number
    3007981285-2014-00838
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 29, 2014
    Manufacturer
    TANDEM DIABETE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FURTHER TROUBLESHOOTING, IT WAS IDENTIFIED PATIENT HAD CHANGED PUMP SETTING WITHOUT DOCTORS APPROVAL. REPORTER ALSO INDICATED PATIENT HAD VIRUS AND WAS USING 2X BASAL RATE.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING PATIENT WAS HOSPITALIZED FOR HIGH BG' (300'S MG/DL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314552 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R