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

Model Number	MT22719-PNK
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The g5 system is associated with product code pqf.Product code pqf is not currently available.
Event or Problem Description
Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2017, the receiver displayed err121.No additional patient or event information is available.No product or data were returned for evaluation.The complaint could not be confirmed.A root cause could not be determined.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint receiver was returned for evaluation.The device was visually inspected and no defect was found.The receiver was charged and rebooted.The receiver log was reviewed firmware errors were observed.The reported event of an error icon display 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: 6287246
• Report Number: 3004753838-2017-10377
• Device Sequence Number: 16306864
• Product Code: PQF
• UDI-Device Identifier: 00386270000262
• UDI-Public: (01)00386270000262(241)STK-GF-PNK(10)5213254
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 01/06/2017

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: STK-GF-PNK
• Device Lot Number: 5213254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2017
• Supplement Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 01/30/2017
• Supplement Report FDA Received Date: 07/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR