BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4163211 · Received October 8, 2014

    Report

    Report Number
    3007981285-2014-09244
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 16, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFO BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED MULTIPLE OCCLUSION ALARMS. REPORTEDLY, THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED (333 MG/DL). CUSTOMER DISCONNECTED FROM PUMP AND REVERTED TO LANTUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633773 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M003314

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other INSULIN: NOVALOG| INFUSION SET: CONTACT DETACH