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

Model Number 9500-35

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Erythema (1840); Pain (1994); Swelling (2091); Reaction (2414)

Event Date 02/19/2016

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).

Event Description

Distributor contacted dexcom on (b)(6) 2016 to report on behalf of patient an allergic reaction that occurred on (b)(6) 2016.The sensor was inserted into the buttocks on (b)(6) 2016.Distributor states that when the reaction began it was just a rash, with itchiness and erythema.Patient also experienced pain and swelling and developed an imposthume that required the use of antibiotics.Patient had additional remedies used to reduce the swelling.Patient was seen by a doctor on (b)(6) 2016 regarding the irritation.After the second visit, the doctor advised that the patient stop using the continuous glucose monitoring device, as the allergic reaction was undoubtedly caused by the sensor patch adhesive.At the time of contact, the rash and the imposthume were slowly disappearing.No additional event or patient information was provided.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• 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: 5594880
• MDR Text Key: 43271444
• Report Number: 3004753838-2016-21272
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/06/2016
• Device Model Number: 9500-35
• Device Catalogue Number: STS-GL-006
• Device Lot Number: 5205051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2015
• 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
• Patient Age: 6 YR
• Patient Weight: 11