BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4852596 · Received June 17, 2015

    Report

    Report Number
    3007981285-2015-34041
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    May 17, 2015
    Report Date
    May 17, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP STOPPED FILL TUBING AT 9.8 UNITS AND REQUESTED A MINIMUM OF 50 UNITS DURING MULTIPLE ATTEMPTS OF THE LOAD PROCESS. THE CUSTOMER INDICATED THEIR BLOOD GLUCOSE LEVEL MAY HAVE GONE UP A BIT DUE TO NOT BEING ABLE TO LOAD A CARTRIDGE RIGHT AWAY, BUT THE EXACT VALUE COULD NOT BE DETERMINED AS THE CUSTOMER DECLINED TO TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395623 TANDEM T:SLIM INSULIN DELIVERY SYSTEM LZG TANDEM DIABETES CARE INC. 004628 M015153

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other