BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 8764471 · Received July 5, 2019

    Report

    Report Number
    3013756811-2019-38248
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 12, 2019
    Report Date
    July 5, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER BELIEVED THE PUMP WAS NOT DELIVERING BASAL INSULIN. TANDEM TECHNICAL SUPPORT EXAMINED THE PUMP DATA LOGS AND FOUND THE PUMP HAD DECLARED MULTIPLE OCCLUSION ALARMS. ADDITIONALLY, IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CARTRIDGE ALARM (ALARM 1) DURING A BOLUS DELIVERY. REPORTEDLY, THE CARTRIDGE WAS DAMAGED. LASTLY, THE CUSTOMER RECEIVED MULTIPLE CARTRIDGE CHANGE ERRORS DURING THE LOADING SEQUENCE. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, AN O-RING WAS FOUND ON THE PNEUMATIC TAP RESULTING IN THE CARTRIDGE NOT FITTING ON THE PUMP. THE CUSTOMER REMOVED THE O-RING AND SUCCESSFULLY RELOADED THE CARTRIDGE ONTO THE PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 140-315 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558184 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 34 YR INSULIN: NOVOLOG/NOVORAPID, INFUSION SET: TRUSTEEL