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

Model Number 9500-27

Device Problem Detachment Of Device Component (1104)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 07/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).On rare occasions, the sensor wire may break or detach from the sensor pod.If a sensor wire breaks under the skin with no portion of it visible, don't remove it.Contact your healthcare professional if you have redness, swelling, or pain at the insertion site.

Event Description

Patient's mother contacted dexcom on 07/02/2016, to report a detached sensor wire and adverse event that occurred on (b)(6) 2016.The sensor insertion was at the abdomen on the (b)(6) 2016.The patient's mother stated that the detached wire remained under the patient's skin and the patient was feeling pain.The patient's mother stated that she first called dexcom at approximately 7:45 pm (b)(6) 2016.Then the patient's mother called the patient's endocrinologist at approximately 9pm and the endocrinologist recommended the patient's mother take the patient to emergency room to have sensor wire removed.The patient's mother took the patient to the emergency room at approximately 10pm.At approximately 12 am the patient had sensor removed by the emergency room doctor.The patient was released from the emergency room at approximately 1 am (b)(6) 2016.No further event or patient information is available.

Manufacturer Narrative

(b)(4) describe event or problem - additional, serial number - additional, additional information/device evaluation, device evaluated by manufacturer - additional, event problem and evaluation codes - additional.

Event Description

The complaint device was returned for evaluation.A visual inspection was performed and the sensor wire was detached from the housing puck.The customer complaint was confirmed.A root cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the first follow-up; a sensor (serial #(b)(4)/lot #5211749) was returned for evaluation.It cannot be verified if this is the device at fault.A visual inspection was performed and found that the wire is attached to the sensor and housing puck.The customer's complaint of a missing/detached sensor wire was not confirmed.A root cause could not be determined.

• 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: 5823987
• MDR Text Key: 50509913
• Report Number: 3004753838-2016-38794
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)5211749(17)170503
• 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: 07/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/03/2017
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: 5211749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2016
• 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 Outcome(s): Other
• Patient Age: 23 MO
• Patient Weight: 10