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

Model Number	MT22430-PNK
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017 the receiver had no audio output.No additional event or patient information is available.No product or data were provided for evaluation.The reported no audio output could not be confirmed.A root cause could not be determined.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint device was returned for evaluation.The device was externally visually inspected and no defect was found.A review of the downloaded receiver log did not find any issues related to the customer complaint.Functional testing and a manual drop test for intermittency was performed and the tests failed.The receiver case was opened for further evaluation.A visual interior inspection was performed and the inspection passed.A speaker resistance test was performed and confirmed the reported event of no audio output.The root cause was determined to be a defective speaker assembly.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
• Common Device Name: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• MDR Report Key: 6518567
• Report Number: 3004753838-2017-32475
• Device Sequence Number: 19007850
• Product Code: MDS
• UDI-Device Identifier: 10386270000108
• UDI-Public: (01)10386270000108(241)STK-KD-PNK(10)5195785
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2017

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: MT22430-PNK
• Device Catalogue Number: STK-KD-PNK
• Device Lot Number: 5195785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 05/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3004753838-02/29/16-001C
• Patient Sequence Number: 1
• Patient Age: 13 YR