BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 7310394 · Received March 2, 2018

    Report

    Report Number
    3013756811-2018-06075
    Event Type
    Injury
    Date Received
    March 2, 2018
    Date of Event
    February 7, 2018
    Report Date
    March 2, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 COULD NOT BE VERIFIED; HOWEVER, A DIFFERENT ISSUE WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP DATA WAS INACCURATE. REPORTEDLY, ON MULTIPLE OCCASIONS, THE CUSTOMER DELIVERED BOLUS DOSINGS AROUND 7 AM, AND PUMP HISTORY DISPLAYED THAT THE BOLUS REQUESTS HAD BEEN DELIVERED AT 9:09 AM AND 10:13 AM. REVIEW OF THE PUMP DATA LOGS BY TANDEM TECHNICAL SUPPORT VERIFIED THAT THE BOLUS DOSAGES HAD BEEN PROGRAMMED AND DELIVERED AT 9:09 AM AND 10:13 AM; HOWEVER, THE CUSTOMER MAINTAINED THAT THE DATA WAS INACCURATE. BLOOD GLUCOSE (BG) LEVEL RANGED FROM 200-530 (MG/DL); HOWEVER, THE CUSTOMER WAS UNABLE TO CONFIRM IF THE REPORTED ISSUE WAS THE SUSPECTED CAUSE OF THE ELEVATED BG LEVEL. A CORRECTION BOLUS WAS DELIVERED AND THE INFUSION SET WAS CHANGED TO ADDRESS BG LEVEL. REPORTEDLY, THE CUSTOMER CONTINUED USING THE PUMP FOR INSULIN THERAPY, AND IN ADDITION, HAD MANUAL INJECTIONS AVAILABLE AS ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153974 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other INSULIN: NOVOLOG, INFUSION SET: CLEO