MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number	MT22608-BLU
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Pt mother reports loss of connection.Allegies that the receiver is at fault.
Additional Manufacturer Narrative
Com-(b)(4).
Event or Problem Description
Dexcom was made aware on (b)(4)2018 that on (b)(6)2018, a loss of connection between the transmitter and display device occurred.No product or data was provided for evaluation.The complaint confirmation of a loss of connection could not be determined.A probable cause could not be determined.No additional patient or event information is available.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The product was evaluated.An external visual inspection was performed and passed.Charge and boot testing was performed and passed.A (b)(4) bluetooth device pairing test was performed and failed.A receiver functional test was performed and failed due to failure of the radio frequency (rf) test.A review of the share logs was not performed as there was no data found within the investigation window.The allegation was confirmed.No injury or medical intervention was reported.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Common Device Name: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• MDR Report Key: 7287454
• Report Number: 3004753838-2018-018478
• Device Sequence Number: 19362082
• Product Code: MDS
• UDI-Device Identifier: 30386270000201
• UDI-Public: 30386270000201
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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,Followup
• Report Date (Section B): 04/26/2019

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: MT22608-BLU
• Device Catalogue Number: STR-PR-BLU
• Device Lot Number: 5227001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 02/24/2018; 04/23/2019
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 02/26/2018; 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 27