BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 7039128 · Received November 16, 2017

    Report

    Report Number
    3007981285-2017-34604
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Date of Event
    October 16, 2017
    Report Date
    November 16, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THE ALLEGED MALFUNCTION WAS IDENTIFIED IN THE PUMP LOGS; HOWEVER, NO FAILURE WAS IDENTIFIED. ADDITIONALLY, A DIFFERENT ISSUE WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE INTERMITTENT ALTITUDE ALARMS OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 211-350 MG/DL. REPORTEDLY, THE CUSTOMER WAS ULTIMATELY ABLE TO CLEAR THE ALARMS AND RESUME INSULIN DELIVERY. THE CUSTOMER REPORTED THAT THE PUMP WOULD CONTINUE TO BE USED FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816853 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR