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

Model Number	MT22719-PNK
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Dexcom was made aware on (b)(6) 2017 that the receiver initialized without a manual restart on (b)(6) 2017.There was no report injury or medical intervention.No additional patient or event information is available.The device has been received for evaluation.A follow-up report will be submitted once the evaluation is complete.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint device was returned for evaluation.The device was visually inspected and no defect was found.Performed receiver download review.The unit displays initialization screen and continuously resets without displaying trend graph or date/time set.The reported event of initializing screen without manual restart was confirmed during log review.A root cause could not be determined.

• 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: 6286312
• Report Number: 3004753838-2017-08849
• Device Sequence Number: 1226233
• Product Code: MDS
• UDI-Device Identifier: 00386270000262
• UDI-Public: (01)00386270000262(241)MT22719-PNK(10)5220389(17)NA
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MT22719-PNK
• Device Catalogue Number: STR-GF-PNK
• Device Lot Number: 5220389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2017
• Supplement Report FDA Received Date: 02/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 57