BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 7495639 · Received May 8, 2018

    Report

    Report Number
    3013756811-2018-15435
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    April 24, 2018
    Report Date
    May 8, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CARTRIDGE INSTRUCTIONS FOR USE: REPLACE THE CARTRIDGE EVERY 48 HOURS IF USING HUMALOG; EVERY 72 HOURS IF USING NOVOLOG. PER THE CARTRIDGE INSTRUCTIONS FOR USE: MAKE SURE THAT INSULIN IS AT ROOM TEMPERATURE BEFORE FILLING THE CARTRIDGE NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN OCCLUSION ALARM OCCURRED. A SUPPLY CHANGE WAS PERFORMED RESOLVING THE OCCLUSION. ADDITIONALLY, IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED WITHIN THE INFUSION SET TUBING AND THE CARTRIDGE TUBING. THE CUSTOMER PRIMED THE TUBING SUCCESSFULLY REMOVING THE AIR BUBBLES. REPORTEDLY, THE CUSTOMER HAD BEEN USING THE CURRENT SUPPLIES FOR 4 DAYS AND HAD LOADED THE CARTRIDGE WITH COLD INSULIN. TANDEM TECHNICAL SUPPORT ADVISED THE CUSTOMER TO FOLLOW PROPER LABELING OF PUMP SUPPLIES. BLOOD GLUCOSE LEVEL RANGED BETWEEN 143-192 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337516 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 M021257

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR INFUSION SET: AUTOSOFT 90, INSULIN: HUMALOG