BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5492491 · Received March 10, 2016

    Report

    Report Number
    3007981285-2016-71132
    Event Type
    Malfunction
    Date Received
    March 10, 2016
    Date of Event
    February 16, 2016
    Report Date
    February 18, 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 TANDEM T:SLIM PUMP USER GUIDE INDICATES THAT NOVOLOG INSULIN WAS TESTED AND FOUND TO BE SAFE FOR USE IN THE T:SLIM PUMP FOR UP TO 72 HOURS. IT ALSO STATES THAT REUSE OF CARTRIDGES MAY RESULT IN OVER-INFUSION OR UNDER-INFUSION AND MAY CAUSE SERIOUS INJURY OR DEATH. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE, INTERMITTENT OCCLUSION ALARMS. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL RANGED FROM 170 - 188 MG/DL AND A BOLUS WAS DELIVERED VIA THE PUMP TO ADDRESS THE BG LEVEL. THE CUSTOMER CHANGED THE SUPPLIES TO THE PUMP. THE CUSTOMER STATED THAT THE CARTRIDGE WAS REUSED AND THAT THE SUPPLIES TO THE PUMP ARE CHANGED ABOUT EVERY 4 DAYS. AS THE SUPPLIES TO THE PUMP HAD BEEN CHANGED PRIOR TO CONTACTING TANDEM TECHNICAL SUPPORT, A PUMP SYSTEM CHECK TO DETERMINE A POSSIBLE CAUSE OF THE OCCLUSION WAS UNABLE TO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149147 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR INSULIN: NOVOLOG, INFUSION SET: INSET