BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 8358473 · Received February 21, 2019

    Report

    Report Number
    3013756811-2019-08417
    Event Type
    Malfunction
    Date Received
    February 21, 2019
    Date of Event
    January 22, 2019
    Report Date
    February 21, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE FAILURE INVESTIGATION HAS BEEN PERFORMED AND THE ALLEGED ISSUE WAS VERIFIED IN THE PUMP LOGS; HOWEVER, INVESTIGATION COULD NOT BE COMPLETED AS THE CARTRIDGE WAS NOT RETURNED. THE INFORMATION WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENT OCCLUSIONS OCCURRED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 180-350 MG/DL. REPORTEDLY, THE ALARMS WERE CLEARED AND INSULIN DELIVERY RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153124 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR INSULIN: NOVOLOG