BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 6191226 · Received December 20, 2016

    Report

    Report Number
    3007981285-2016-26521
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 11, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE, INTERMITTENT OCCLUSION ALARMS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM NOT BEING IMPACTED TO THE LOW 200S (BELOW 240 MG/DL). A CAUSE OF THE PAST OCCLUSIONS COULD NOT BE DETERMINED. A PUMP SYSTEM CHECK WAS PERFORMED USING THE CURRENT SUPPLIES ON THE PUMP. INSULIN WAS OBSERVED EXITING FROM THE INFUSION SET TUBING AND THE CARTRIDGE TUBING; HOWEVER, AN OCCLUSION ALARM SOUNDED. TANDEM TECHNICAL SUPPORT REVIEWED THE PUMP DATA AND CONFIRMED THE REPORTED INFORMATION. THE CUSTOMER WAS TO CONTINUE TO USE THE PUMP TO MANAGE DIABETES UNTIL A REPLACEMENT PUMP WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839695 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR INFUSION SET: INSET, INSULIN: HUMALOG