DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM; MDS
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Catalog Number STS-GL-011 |
Device Problems
Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Purulent Discharge (1812); Erythema (1840); Reaction (2414)
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Event Date 05/30/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The user's guide states: 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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Patient contacted dexcom on (b)(6) 2016 to report that they experienced a skin reaction on (b)(6) 2016.The sensor was inserted into the arm on (b)(6) 2016.Reaction was located on the arm under the sensor at the insertion point, and described as red, bumpy, and with pus.Affected area was treated with hydrocortisone prescribed on (b)(6) 2016 for a previous reaction with a pump.At the time of contact, patient is doing well.No additional patient or event information was provided.The sensor was inserted into the arm.The product labeling indicates that sensor insertion is not approved in sites other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years).
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Search Alerts/Recalls
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