BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4121140 · Received September 24, 2014

    Report

    Report Number
    3007981285-2014-07742
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP SAME DAY INDICATES THAT CUSTOMER DRANK A DIET COKE AND WAS FEELING BETTER. 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

    RECEIVED INFORMATION THAT CUSTOMER AWOKE WITH BLOOD GLUCOSE LEVEL AT 183MG/DL AND INTENDED TO GIVE HERSELF A 7 UNIT BOLUS, BUT UNINTENTIONALLY INITIATED A 20+ UNIT BOLUS. REPORTEDLY, CUSTOMER HAD NOT CHECKED IF BLOOD GLUCOSE (BG) LEVEL WAS IMPACTED BUT KNEW THAT BG LEVEL WOULD BE IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595004 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other