MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 9500-44

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Bruise/Contusion (1754); Purulent Discharge (1812); Erythema (1840); Inflammation (1932); Reaction (2414)

Event Date 05/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The dexcom g4 platinum continuous glucose monitoring system user's guide states: inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (e.G., redness, swelling, bruising, itching, scarring or skin discoloration).Detached sensor wires referenced are being reported under mfr #'s 3004753838-2016-70007 and 3004753838-2016-22783.

Event Description

Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient experienced a skin reaction.The sensor was inserted into the thigh.Patient reported that in (b)(6) 2016, she removed a sensor from her leg on the 6th day of wear, due to the tape pulling away and leaving some sensor exposed.Initially, there was just the usual small bump on the skin which normally disappeared within 48 hours.However, within 48 hours, there was a clear bump under the skin that was larger than normal.Two weeks passed and the bump continued to grow and also changed slightly in color, resembling a bruise.The patient visited the doctor at the end of (b)(6) 2016 and although he acknowledged that something was not quite right, he was not worried about infection and was content to wait and see what happened.Over the next few weeks, the patient visited numerous times as the bump grew and became redder, more enflamed, was very painful.There also appeared to be an abscess of some kind under the skin.The patient was concerned that a piece of sensor was stuck in the skin but was told it did not appear so.The patient tried to stress how small the sensors are but was told it was unlikely.Eventually, the patient was prescribed antibiotics at the emergency room which at first, appeared not to help.However, shortly after in (b)(6), the abscess burst and at this point the open wound did respond to antibiotics.The patient was further placed on a 2 week course.Again, the doctor advised it was unlikely anything was caught inside as the lump was not hard.It did, however, have a minute dark area at the center.A few weeks passed and when inspecting the site, the patient could see something protruding from the skin.The patient pulled at it and out came two small shards of foil-like material, along with a significant amount of fluid.Patient spoke to her diabetes consultant who conceded that it was likely to have been part of the sensor.Additionally, patient reported that she was due to see the doctor again as he probably wanted to drain the abscess, since it was persistently struggling to heal.Patient also expressed concern about potential damage to her leg.No additional patient information is available.No product or data was returned for evaluation.However, photographs of the reaction were provided for evaluation.The reported event of skin reaction was confirmed.A root cause could not be determined.Labeling indicates: sensor placement and insertion is not approved for sites other than the belly (abdomen).

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 6012820
• MDR Text Key: 56910365
• Report Number: 3004753838-2016-22784
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 9500-44
• Device Catalogue Number: STS-GF-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other