BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6110954 · Received November 17, 2016

    Report

    Report Number
    3007981285-2016-20190
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    October 29, 2016
    Report Date
    October 30, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    ON (B)(6) 2017: CGM RECORDED A BLOOD GLUCOSE (BG) LEVEL OF 41 MG/DL AT 3:47AM ON (B)(6) 2016. THERE WERE THREE BOLUS REQUESTS MADE ON (B)(6) 2016; TWO OF THESE BOLUS REQUESTS WERE MADE WITHOUT THE USER ENTERING CURRENT BG LEVEL. THE USER COMPLETED A CARTRIDGE CHANGE SEQUENCE AT 6:25PM ON (B)(6) 2016. A BOLUS REQUEST WAS MADE JUST AFTER MIDNIGHT ON (B)(6) 2016. THERE WERE NO ERRATIC BASAL RATE ADJUSTMENTS. MAKING BOLUS REQUESTS WITHOUT ENTERING CURRENT BG LEVEL AND STILL HAVING INSULIN ON BOARD (ACTIVE INSULIN IN THE BODY) COULD LEAD TO LOW BG LEVELS. IF THE USER DID NOT DISCONNECT DURING "TUBING FILL" PROCESS OF THE CARTRIDGE CHANGE SEQUENCE, INSULIN COULD BE DELIVERED AND BG LEVELS COULD DROP. PUMP LOGS DO NOT INDICATE THAT THE INSULIN PUMP CAUSED LOW BG LEVELS. THERE IS NO EVIDENCE OF A MALFUNCTION OR FAILURE OF THE PUMP. MOST LIKELY, THE CAUSE OF THE LOW BG IS DUE TO THE USER NOT CORRECTLY ESTIMATING THE 12:10AM MEAL OF 75 GRAMS OF CARBOHYDRATES, WHICH THEY DELIVERED 4.04 UNITS OF INSULIN FOR. THE FIRST LOW BG WAS 1 ½ AFTER THIS BOLUS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL OF LESS THAN 40 (MG/DL). CUSTOMER CONSUMED CARBOHYDRATES WITH THE ASSISTANCE OF THEIR FAMILY MEMBER TO TREAT THEIR BG LEVEL. RECOMMENDATION WAS MADE TO CONSULT WITH THEIR HEALTH CARE PROVIDER TO DISCUSS DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761518 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention