BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3900327 · Received May 5, 2014

    Report

    Report Number
    3007981285-2014-00557
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PHONE NURSE MENTIONED PATIENT DID NOT RECEIVE INSULIN DUE TO NOT CHANGING AN EMPTY CARTRIDGE. NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO DKA. AS PER HOSPITAL'S NURSE PATIENT WAS SICK AND HAD BEEN OFF INSULIN FOR A FEW HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268101 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R