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

Model Number 9500-27

Device Problem Component Missing (2306)

Patient Problems Increased Sensitivity (2065); Foreign Body In Patient (2687)

Event Date 05/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The first sensor wire (detached) is being reported under mfr 3004753838-2016-03452.

Event Description

Patient's mother contacted dexcom on 05/18/2016 to report two (2) missing sensor wires that occurred on (b)(6) 2016.The patient's mother reported that both sensors were retained on the same day, one after another.The sensor was inserted into the abdomen on (b)(6) 2016.The patient mother reported patient was feeling tenderness at the insertion site.Patient's mother called endocrinologist who told her to take the patient to the primary care physician.On (b)(6) 2016, patient's mother took patient to the primary care physician.X-rays were taken and confirmed there was one (1) sensor in the body.They could not find the second sensor wire as patient was wearing a sensor on the other side of abdomen.The doctor referred the patient's mother to a pediatric surgeon.On (b)(6) 2016, patient's mother took patient to a pediatric surgeon for consultation.No procedures were performed.Patient's mother was told to monitor the site.No follow up visit was scheduled.At the time of contact, patient was in good condition.No further event or patient information is available.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

A sensor pod was returned for evaluation.A visual inspection was performed and the sensor wire was missing from the sensor pod.The reported event of a missing sensor wire was confirmed; however, it is unknown if the returned deviced is the complaint device.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: 5725449
• MDR Text Key: 47394925
• Report Number: 3004753838-2016-03451
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)5205382(17)161111
• 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: 05/18/2016

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 Expiration Date: 11/11/2016
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: 5205382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2016
• Initial Date FDA Received: 06/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/01/2016; 09/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2015
• 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: 5 YR
• Patient Weight: 19