MAUDE Adverse Event Report: DEXCOM, INC.; CONTINOUS GLUCOSE MONITOR

Model Number 9500-27

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

Patient Problem Skin Erosion (2075)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Labeling indicates: 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

Dexcom was made aware on 02/03/2017, that on (b)(6) 2017, the patient experienced a skin reaction.The sensor was inserted into the abdomen on (b)(6) 2017.The reaction was located on the abdomen and was described as ulcerated under the sensor, unless protective barrier is applied.On (b)(6) 2017, patient reached out to a licensed practical nurse to receive a recommendation for alternative treatment or prevention for this reaction.Date of medical intervention is an approximation.No additional event or patient information was provided.No product or data was returned for evaluation.The reported event could not be confirmed.A root cause could not be determined.

• Brand Name: NI
• Type of Device: CONTINOUS 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: 6375358
• MDR Text Key: 68962899
• Report Number: 3004753838-2017-15877
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)NI(17)NI
• Combination Product (y/n): N
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2017
• 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
• Patient Age: 62 YR