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

Model Number 9500-27

Device Problems Use of Device Problem (1670); Component Missing (2306)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 12/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(6) 2016 that on (b)(6) 2016 the sensor wire was missing.The attempted sensor insertion was at the thigh on (b)(6) 2016.It was reported that the patient used an alternative insertion site.Additionally, it was reported that continuous glucose monitoring (cgm) device is being used on a patient under 2 years of age.No additional event or patient information is available.No product or data were provided for evaluation.The reported missing sensor wire could not be confirmed.A root cause could not be determined.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.Labeling indicates: the dexcom g4 platinum (pediatric) continuous glucose monitoring system is a glucose monitoring device indicated for detecting trends and tracking patterns in persons ages 2 to 17 years with diabetes.However, a root cause for the reported inaccuracy cannot be determined.

Manufacturer Narrative

(b)(4).

Event Description

The sensor was returned for evaluation a visual inspection was performed and the sensor wire was missing from the sensor pod and seal carrier.Due to the missing sensor wire, the sensor wire is considered detached.The reported event of a missing sensor wire was confirmed.A root cause could not be determined.

Manufacturer Narrative

(b)(4).Date received by manufacturer - correction to initial mdr, date should be 01/04/2017.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

Dexcom received additional information from the patient's physician on 01/04/2017 regarding an adverse event.The physician stated that she did not see the sensor wire at the skin side when she removed the sensor pod from the patient's thigh.It was reported that there was an elevated area where the sensor had been inserted.The patient remained in the hospital due to the elevated area not decreasing in size and an x-ray was requested.An x-ray image was provided and confirmed the retained sensor wire in the thigh.No surgical intervention was needed.The physician was able to remove both pieces of the sensor wire from the skin.The patient was discharged from the hospital.Upon follow-up two weeks after the adverse event, the patient's parents has reported that the elevated area is still present; however, it has decreased in size.No further patient or event information is available.

• 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: 6211775
• MDR Text Key: 63490566
• Report Number: 3004753838-2016-63713
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)5218525(17)170912
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/12/2017
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: 5218525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2016
• 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 Age: 1 DA
• Patient Weight: 4