BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3842679 · Received May 19, 2014

    Report

    Report Number
    3007981285-2014-00700
    Event Type
    Injury
    Date Received
    May 19, 2014
    Date of Event
    April 19, 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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REC'D FOR EVALUATION; HOWEVER, EVALUATION IS NOT YET COMPLETE. A F/U MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295061 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628 M002426

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other INSULIN: HUMALOG| INFUSION SET: INSET 30