MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM; MDS

Model Number 9500-27

Device Problems Detachment Of Device Component (1104); Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient's mother contacted dexcom on (b)(6) 2016 to report that the patient experienced a detached sensor wire on (b)(6) 2016.The sensor was inserted into the thigh on (b)(6) 2016.Patient's mother was unable to find the sensor wire upon removal of the sensor pod.Patient's mother took the patient to the urgent care at approximately 7:00pm on (b)(6) 2016.The patient was admitted and had an x-ray performed.The x-ray found that the sensor wire was lodged under the patient's skin.The patient was discharged at approximately 9:00pm.On (b)(6) 2016, the patient had a second x-ray performed and it confirmed that the sensor wire was stuck between the muscle tissue and skin.The doctor could not remove the sensor wire and referred the patient to a different doctor, who surgically removed the sensor wire on (b)(6) 2016.No additional event or patient information was provided.The sensor was inserted into the thigh.The dexcom g5 mobile continuous glucose monitoring system states: 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.Additionally, the transmitter was removed prior to removal of the sensor pod.The dexcom g5 mobile continuous glucose monitoring system states: do not remove the transmitter before removing the sensor pod from your body.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

A sensor (serial number (b)(4)/lot number 5205269) was returned for evaluation a visual inspection was performed and the sensor wire was missing from the sensor pod and housing puck.Due to the missing sensor wire, the sensor wire is considered detached.The reported event of a detached sensor wire was confirmed.A root cause could not be determined.However, it is unknown if the returned product is the complaint device.

• Brand Name: DEXCOM G5 MOBILE 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: 5740659
• MDR Text Key: 47900648
• Report Number: 3004753838-2016-03521
• 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,Followup
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• 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
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2016
• 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): Hospitalization; Other
• Patient Age: 16 YR
• Patient Weight: 81