BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4852604 · Received June 17, 2015

    Report

    Report Number
    3007981285-2015-34356
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    May 20, 2015
    Report Date
    May 20, 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
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TANDEM T:SLIM PUMP USER GUISE INDICATES THAT NOVOLOG HAS BEEN TESTED FOR UP TO 72 HOURS. THE PRODUCT HAS NOT BEEN RETURNED FOR EVAL. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER REC'D MULTIPLE OCCLUSION ALARMS DURING BASAL AND BOLUS DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 300 MG/DL. THE CUSTOMER CHANGED THE CARTRIDGE AND INFUSION SET. AS THE CUSTOMER HAD CHANGED THE SUPPLIES PRIOR TO CONTACTING TANDEM TECHNICAL SUPPORT, A SYSTEM CHECK TO DETERMINE A POSSIBLE CAUSE OF THE OCCLUSIONS WAS UNABLE TO BE PERFORMED. THE CUSTOMER INDICATED A CARTRIDGE HAD BEEN USED FOR FOUR DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395600 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M003643

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other INFUSION SET: INSET| INSULIN: NOVOLOG