BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4961510 · Received July 30, 2015

    Report

    Report Number
    3007981285-2015-50186
    Event Type
    Injury
    Date Received
    July 30, 2015
    Date of Event
    June 1, 2015
    Report Date
    July 8, 2015
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED DUE TO THE OCCLUSIONS. THE CUSTOMER DISCONNECTED FROM THE PUMP AND REVERTED TO MANUAL INSULIN INJECTIONS FOR DIABETES MANAGEMENT. AS THE CUSTOMER WAS NOT RECEIVING AN ALARM WHEN TANDEM TECHNICAL SUPPORT WAS CONTACTED, TROUBLESHOOTING TO DETERMINE A POSSIBLE CAUSE OF THE PAST OCCLUSIONS WAS UNABLE TO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495345 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other