BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM --

    MDR report key: 6151956 · Received December 7, 2016

    Report

    Report Number
    3007981285-2016-22716
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 15, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICAL DIABETES SPECIALIST (CDS) THAT THE CUSTOMER'S PUMP DATA LOGBOOK SHOWS THAT THE CUSTOMER ENTERED 200 GRAMS OF CARBOHYDRATES OR MORE INTO THE PUMP ON SEVERAL EVENT DATES. THE CDS CALLED TANDEM TECHNICAL SUPPORT TO INQUIRE IF A BOLUS HAD BEEN DELIVERED AFTER THE ENTRIES. REPORTEDLY, THE CDS BELIEVES THE CUSTOMER IS EXPERIMENTING WITH THE PUMP AND DID NOT INTEND TO BOLUS FOR CARBOHYDRATE VALUES BETWEEN 200-999 GRAMS. REVIEW OF THE CUSTOMER'S PUMP DATA LOGBOOK BY TANDEM TECHNICAL SUPPORT SHOWED MULTIPLE ENTRIES OF CARBOHYDRATES VALUES RANGING FROM 199-999 GRAMS THAT HAD BEEN INPUT BY THE USER; HOWEVER, THE BOLUS REQUESTS FOR THESE ENTRIES HAD NOT BEEN DELIVERED. ADDITIONALLY, THE CDS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804089 TANDEM T:SLIM INSULIN DELIVERY SYSTEM -- INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR