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

Model Number	9500-27
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) the g5 system is associated with product code pqf.Product code pqf is not currently available in common device name.
Event or Problem Description
Dexcom was made aware on 01/05/2017, that on (b)(6) 2016, the patient experienced a broken sensor wire that remained under the skin.The sensor was inserted in the patient's abdomen on (b)(6) 2016.Patient's mother reported a mass on the skin where the sensor was inserted.On (b)(6) 2016, the patient saw his doctor who referred him to get an ultrasound at the hospital.On (b)(6) 2016, the patient got an ultrasound which showed a possible sensor fragment about 1 cm long.An x-ray was also taken, however results were not available at the time of contact.At the time of contact, the patient's current condition was good.No product was provided for evaluation.The reported event could not be confirmed.A root cause cannot be determined.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Common Device Name: MDS
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• MDR Report Key: 6301147
• Report Number: 3004753838-2017-01162
• Device Sequence Number: 1017005
• Product Code: MDS
• UDI-Device Identifier: 10386270000016
• UDI-Public: (01)10386270000016(241)9500-27(10)5215262(17)170728
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P120005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2017

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/28/2017
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: 5215262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2017
• Initial Report FDA Received Date: 02/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 4 YR