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

Model Number	9500-27
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Dexcom was made aware on 07/29/2016, to report a detached sensor wire that occurred on (b)(6) 2016.The sensor insertion was at the abdomen on the (b)(6) 2016.There was no report any injury or medical intervention.No additional event or patient information is available.
Additional 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 or Problem Description
Dexcom was made aware on 07/29/2016, to report a detached sensor wire that occurred on (b)(6) 2016.The sensor insertion was at the abdomen on the (b)(6) 2016.Patient stated that the sensor wire was under his skin.The patient went to a minor emergency clinic on (b)(6) 2016.An anteroposteriorly x-ray was performed of the abdomen and nothing unusual was found.No additional event or patient information is available.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Common Device Name: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• MDR Report Key: 5895153
• Report Number: 3004753838-2016-49519
• Device Sequence Number: 724430
• Product Code: MDS
• UDI-Device Identifier: 10386270000016
• UDI-Public: (01)10386270000016(241)9500-27(10)5209482(17)170228
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Followup
• Report Date (Section B): 07/29/2016

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2017
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: 5209482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2016
• Supplement Report FDA Received Date: 08/31/2016
• 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: 58 YR
• Patient Weight: 95