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Model Number 9500-27 |
Device Problems
Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Itching Sensation (1943); Peeling (1999); Reaction (2414)
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Event Date 07/02/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Labeling indicates: inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (redness, swelling, bruising, itching, scarring or skin discoloration).
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Event Description
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Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient experienced a skin reaction.The sensor was inserted into the arm on (b)(6) 2017.After the full 7 days of the sensor session, the patient removed the sensor and noticed that the skin was peeling and it was red and itchy.The patient treated the affected area with hydrocortisone cream that was prescribed by the dermatologist on (b)(6) 2017 for a previous skin reaction.At the time of event, the patient was doing okay.No additional or event information is available.The sensor was inserted into the arm.Labeling indicates: do not insert the sensor in sites other than the belly (abdomen) or upper buttocks.Use in other sites might cause sensor glucose readings to be inaccurate and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
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Search Alerts/Recalls
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