BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3842693 · Received May 19, 2014

    Report

    Report Number
    3007981285-2014-00701
    Event Type
    Injury
    Date Received
    May 19, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 19, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN REC'D. A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REC'D INFO STATING CUSTOMER HAS REC'D MULTIPLE OCCLUSION ALARMS. REPORTEDLY, THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295071 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other INFUSION SET: CLEO 90| INSULIN: NOVOLOG