BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5976717 · Received September 26, 2016

    Report

    Report Number
    3007981285-2016-10809
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    September 3, 2016
    Report Date
    September 3, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 INVESTIGATION HAS BEEN COMPLETED AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. HOWEVER, DIFFERENT ISSUES WERE FOUND. ISSUES IDENTIFIED: FAULTY VIBE MOTOR: 120, 25; INCOMPLETE DATA LOGS: 3235, 23, 3372.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALTHOUGH THE PUMP WAS ABLE TO BEEP AND VIBRATE, IT WAS NOTED TO OTHERWISE BE UNRESPONSIVE AND STOPPED ALL INSULIN DELIVERY. AFTER CHARGING THE PUMP, THE PUMP TURNED ON AND UPON REVIEWING THE PUMP DATA DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, IT WAS CONFIRMED THAT A MALFUNCTION ALARM HAD OCCURRED. THERE WAS NO IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. IT WAS INDICATED THAT THE CUSTOMER WOULD OBTAIN MANUAL INJECTIONS AS ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628105 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR