BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6076825 · Received November 3, 2016

    Report

    Report Number
    3007981285-2016-18148
    Event Type
    Injury
    Date Received
    November 3, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 14, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE T:SLIM G4 PUMP USER GUIDE STATES THAT THE T:SLIM G4 PUMP SHOULD BE TAKEN OFF AND REMOVED FROM THE PROCEDURE ROOM DURING AN X-RAY, COMPUTED TOMOGRAPHY (CT) SCAN, MAGNETIC RESONANCE IMAGING (MRI), POSITRON EMISSION TOMOGRAPHY (PET) SCAN OR OTHER EXPOSURE TO RADIATION. IN ADDITION, DO NOT EXPOSE YOUR PUMP, TRANSMITTER, OR SENSOR TO PACEMAKER/AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) PLACEMENT OR REPROGRAMMING, CARDIAC CATHETERIZATION, OR NUCLEAR STRESS TEST. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED AND THE PUMP STOPPED ALL INSULIN DELIVERY. REPORTEDLY, THE CUSTOMER HAD THE PUMP IN THE SAME ROOM AS THEM WHEN THEY RECEIVED AN X-RAY EARLIER IN THE DAY. CONTACT REPORTED THAT THE CUSTOMER EXPERIENCED A BLOOD GLUCOSE LEVEL OF 330 (MG/DL) THAT WAS ADDRESSED WITH AN INSULIN INJECTION. IT WAS INDICATED THAT THE CUSTOMER HAD MANUAL INJECTIONS AVAILABLE FOR ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728082 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other