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

Model Number	MT22949
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that intermittent audio output occurred.No product or data was provided for evaluation.Confirmation of the allegation and a probable cause could not be determined.No injury or medical intervention was reported.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The product was evaluated.An external visual inspection was performed and passed.Charge and boot tests were performed and passed.Receiver functional testing were performed and passed.An audio/vibration test with dexcom global receiver communication tool was performed and passed.A "try it" audio/vibration test was performed and passed.An internal visual inspection was performed and passed.Speaker audio and vibrator intermittent tests were performed and passed.The speaker and vibrator resistance were measured and passed.The receiver log was downloaded and reviewed finding no error related to the complaint.The allegation was not confirmed.A probable cause could not be determined as the allegation was not found.No injury or medical intervention was reported.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Subsequent to the initial mdr, a correction is required.

• Brand Name: DEXCOM G5 MOBILE 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: 9659009
• Report Number: 3004753838-2020-010988
• Device Sequence Number: 3319332
• Product Code: PQF
• UDI-Device Identifier: 30386270000157
• UDI-Public: 30386270000157
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/03/2020

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: MT22949
• Device Catalogue Number: STR-MD-001
• Device Lot Number: 5251893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 02/06/2020; 03/03/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 02/27/2020; 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR