BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5746483 · Received June 23, 2016

    Report

    Report Number
    3007981285-2016-86868
    Event Type
    Malfunction
    Date Received
    June 23, 2016
    Date of Event
    May 28, 2016
    Report Date
    June 1, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE TANDEM T:SLIM PUMP USER GUIDE INDICATES THAT HUMALOG INSULIN WAS TESTED AND FOUND TO BE SAFE FOR USE IN THE T:SLIM PUMP FOR UP TO 48 HOURS. 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 WAS 200-227 MG/DL AND A BOLUS WAS DELIVERED TO ADDRESS THE BG LEVEL. AFTER THE ALARMS, THE CUSTOMER WOULD CHANGE THE SUPPLIES ON THE PUMP AND THE OCCLUSION WAS RESOLVED. REPORTEDLY, WHEN THE LAST OCCLUSION HAD OCCURRED, THE CUSTOMER HAD BEEN USING HUMALOG INSULIN IN THE CARTRIDGE FOR 3 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399461 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR