BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6061382 · Received October 27, 2016

    Report

    Report Number
    3007981285-2016-16221
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    October 9, 2016
    Report Date
    October 9, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE REPORTED OCCLUSION WAS VERIFIED IN THE PUMP LOGS; NO FAILURE WAS IDENTIFIED RELATED TO THE OCCLUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE MALFUNCTION 16 ALARMS AND AN OCCLUSION ALARM. THE CUSTOMER CLEARED THE OCCLUSION ALARM BY UNWINDING THE INFUSION SET TUBING FROM AROUND THE PUMP; HOWEVER, THE MALFUNCTION 16 ALARM HAD REOCCURRED AFTER THE PUMP HAD BEEN RESET. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED. THE CUSTOMER HAD INSULIN INJECTIONS TO USE TO MANAGE DIABETES IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713230 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR