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Model Number G6 SENSOR |
Device Problems
Retraction Problem (1536); Activation, Positioning or Separation Problem (2906); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problems
Hemorrhage/Bleeding (1888); Skin Irritation (2076)
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Event Date 01/17/2021 |
Event Type
malfunction
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Event Description
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Two separate failures of dexcom g6 sensor inserter from same lot number.In both cases, the sensor inserter/applicator device failed to retract the sensor insertion needle after having pressed the orange deploy button as instructed.The needle remained inserted in my skin and the inserter device would not disconnect from the plastic sensor body.I pressed the deploy button several more times but was unable to get the needle to retract/device to detach.I was forced to carefully remove the entire system from my skin with needle deployed.This led to bleeding due to the needle being forcefully removed (which is inserted at a 45 degree angle) and skin irritation due to having to remove the adhesive patch which had just been applied to skin using skintac adhesive promoter.I attempted to insert a second new sensor some time later the same day and the same incident happened again.Needle did not retract.Applicator would not detach from sensor body.Both sensors were from the same 3-pack of lot number 5278761.I have experienced the same malfunction once before (unreported) during 2020.Fda safety report id # (b)(4).
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Search Alerts/Recalls
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