BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 6831482 · Received August 30, 2017

    Report

    Report Number
    3007981285-2017-24298
    Event Type
    Injury
    Date Received
    August 30, 2017
    Date of Event
    July 6, 2017
    Report Date
    August 30, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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 THAT THE CUSTOMER EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) LEVELS RANGING FROM 250-266 (MG/DL). REPORTEDLY, THE BG LEVELS RECURRED INTERMITTENTLY THROUGHOUT THE MONTH, AND THE CONTACT SPECULATED THE SUSPECTED CAUSE TO BE DUE TO THE CUSTOMER'S HORMONAL CHANGES DURING GROWTH SPURTS, OR SITE INSERTION AREAS INTO FATTY TISSUE, BUT WAS UNABLE TO POSITIVELY IDENTIFY A ROOT CAUSE. TO ADDRESS THE BG LEVEL, THE CUSTOMER DELIVERED CORRECTION BOLUS OR ADMINISTERED MANUAL INJECTIONS. RECOMMENDATION WAS MADE TO CONSULT WITH HEALTH CARE PROVIDER REGARDING DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610846 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other