BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4852582 · Received June 17, 2015

    Report

    Report Number
    3007981285-2015-35197
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    May 23, 2015
    Report Date
    May 24, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVAL. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL FORM WILL BE SUBMITTED. T:SLIM USER GUIDE INDICATES, PUMP IS TO BE USED WITH INDIVIDUALS 12 YEARS OF AGE AND GREATER, PATIENT IS (B)(6) OLD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS (515 MG/DL). TROUBLESHOOTING WAS PERFORMED AND PUMP PASSED DELIVERY SYSTEM CHECK. CUSTOMER DELIVERED MANUAL INJECTIONS OF LANTUS AND HUMALOG TO STABILIZE HIS BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394616 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other INSULIN: HUMALOG| INFUSION SET: QUICKSET