I wear a tandem t:slim x2 insulin pump and a dexcom g6 cgm sensor.I have had type 1 diabetes for 38 years and i have worn an insulin pump for 32 years.I am very conscientious about my diabetes management.My a1c readings are consistently in the low 6s, and i have no complications.About 7 pm in the evening, january 7, i began to feel as if i were experiencing a low blood sugar incident, but my pump was saying that my bg was at 220.I checked my bg manually and my bg reading was 38.I checked it two more times within five minutes, and i got a 39 and a 38.It was clear that my pump was being given faulty information by the dexcom sensor.Therefore, the tandem control-iq system was pumping dangerously high levels of insulin into my body.The pump said that i had 2.2 units on board, and my actual bg was extremely low.Even after i treated the low bg with orange juice, my bg monitor (checked manually) continued to give me readings in the upper 30s.I called tandem and the representative said the problem was the dexcom sensor.He told me to turn off control-iq, and i did.I also suspended insulin delivery.The tandem representative transferred me to the dexcom technical support line.While i was waiting for dexcom to answer, i removed the faulty dexcom sensor and inserted a new one.The dexcom representative said the problem was the sensor, and she said dexcom would send me a replacement.I asked how this could have happened, and she said the "wire may have shifted." the day before this incident i had a similar event.The tandem pump was giving me a reading of 140 for my blood glucose but i felt symptoms of low blood sugar.I tested my bg manually and got a reading of 68.Also, the sensor was operating only sporadically during the day.I checked the date i inserted this sensor and it was january 2, only five days before.I asked the dexcom representative repeatedly how often the dexcom sensor fails in this way, and she said she did not have data.She finally gave me a phone number for the diabetes educator department, and she said i could ask that group for failure data.My concern is that if i had not been alert to my feelings of low bg and had not taken action, i could have gone into a severe diabetic condition.I calibrated the sensor several times on january 6, when the pump gave me an erroneous bg of 140.This sensor was clearly faulty, and the dexcom representative said that the sensors are safe.But there seems to be a lack of proper safety parameters in the tandem pump and the dexcom sensor to allow such a life-threatening discrepancy to occur.Fda safety report id# (b)(4).
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