BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4840229 · Received June 11, 2015

    Report

    Report Number
    3007981285-2015-33232
    Event Type
    Injury
    Date Received
    June 11, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 12, 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
    IN, 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 BY THE CONTACT THAT THE CUSTOMER RECEIVED MULTIPLE OCCLUSION ALARMS DURING BOLUS DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 376 MG/DL. AS THE CUSTOMER CHANGED THE CARTRIDGE AND INFUSION SET PRIOR TO CONTACTING TANDEM TECHNICAL SUPPORT, TROUBLESHOOTING TO DETERMINE THE CAUSER OF THE OCCLUSION WAS UNABLE TO BE PERFORMED. THE CONTACT INDICATED THAT ANOTHER TYPE OF INFUSION SET WAS GOING TO BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383304 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other INFUSION SET: INSET