MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE 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 02/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The g5 system is associated with product code pqf.

Event Description

Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017 the sensor wire was missing.The attempted sensor insertion was at the leg.Reportedly, the patient removed the transmitter prior to removing the sensor pod.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 component of the dexcom g5 mobile system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years).The placement and insertion of the sensor component of the dexcom g5 mobile system is not approved for other sites.If placed in other areas, the dexcom g5 mobile system may not function properly.Labeling indicates: do not remove the transmitter before removing the sensor pod from your body.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the initial mdr, dexcom received additional information on 03/15/2017 regarding an adverse event.The patient contacted their physician on (b)(6) 2017 and stated that they inserted the sensor into their thigh.It was reported that the sensor did not start up nor function.The patient did not visualize the sensor wire at the skin side of the sensor pod when they removed the sensor pod from their thigh.The patient believes that the sensor wire is retained because when they touch their thigh in the area where the sensor was worn, they could feel something under their skin.At the time of contact with their physician, the patient did not report any signs or symptoms of inflammation or infection.There were no x-rays taken and no treatment was provided as the patient was not seen by their physician.No additional event or patient information is available.

• Brand Name: DEXCOM G5 MOBILE 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: 6399398
• MDR Text Key: 69851371
• Report Number: 3004753838-2017-21272
• 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
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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?: No
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 03/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2017
• 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: 36 YR
• Patient Weight: 83