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

Model Number	MT22719-BLU
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).The g5 system is associated with product code pqf.
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.Data download log was provided by the patient and reviewed for evaluation on 01/13/2017.Complaint for 050 initializing screen without manual restart could not be confirmed.The root cause could not be determined post investigation.
Additional Manufacturer Narrative
(b)(4) describe event or problem - additional describe event or problem - correction to remove statement "data download log was provided by the patient and reviewed for evaluation on 01/13/2017.Complaint for 050 initializing screen without manual restart could not be confirmed.The root cause could not be determined post investigation." device available for evaluation - additional correction/additional information/device evaluation device evaluated by manufacturer - additional event problem and evaluation codes - additional (b)(4).
Event or Problem Description
The complaint device was returned for evaluation.A visual inspection was performed and no physical damage was observed.The receiver was stuck on the initializing screen, shutdown and re-initialized continuously.An interior inspection was performed and the inspection passed.Due to the device perpetually rebooting, the reported event of an initializing screen without a manual restart was confirmed.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: 6286320
• Report Number: 3004753838-2017-08853
• Device Sequence Number: 13460356
• Product Code: MDS
• UDI-Device Identifier: 00386270000279
• UDI-Public: (01)00386270000279(241)MT22719-BLU(10)5220740(17)NA
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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-BLU
• Device Catalogue Number: STR-GF-BLU
• Device Lot Number: 5220740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• 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: 03/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 20