BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4100846 · Received September 12, 2014

    Report

    Report Number
    3007981285-2014-07164
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 15, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE OCCLUSION ALARMS DURING BOLUS DELIVERY. REPORTEDLY, CUSTOMER SMELLED INSULIN CLOSER TO THE CARTRIDGE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED; HOWEVER, CUSTOMER MANAGED BLOOD GLUCOSE LEVEL USING LONG ACTING INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565145 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other INSULIN: NOVOLOG| INFUSION SET: CLEO 90