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

Model Number MT22495-BLU

Device Problem Defective Alarm (1014)

Patient Problems Fall (1848); Hypoglycemia (1912); Seizures (2063)

Event Date 03/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4). Diabetes mellitus is a known cause of hypoglycemia.

Event Description

Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2017, the patient experienced intermittent audio output on the receiver, in addition to an adverse event that occurred. The patient stated that on (b)(6) 2017 he had woke up about 5:35am, continuous glucose monitor (cgm) showed 87mg/dl, with a diagonal down arrow. The patient's blood glucose (bg) meter tested at that time at 103mg/dl and the patient reports dosing a basal insulin. The patient's cgm was under 50mg/dl at 6:15am, then went down to 37mg/dl. The patient stated the cgm receiver vibrated but did not give audible alert. The patient stated that he does not remember after that. The patient stated that he had a seizure and fell on his side. The patient's partner gave the patient glucagon, orange juice, and a peanut butter sandwich. The patient's bg readings went up to 105mg/dl, then the patient's partner took the patient to the doctor's office where he was cared for by a nurse practitioner. The patient had a shoulder x-ray performed, and they checked the patient's tongue, side, and head for trauma. The patient was prescribed hydrocodone for pain, and a new glucagon prescription. The patient was told to take alieve for inflammation, and to gargle with salt water for tongue injury. At time of contact the patient's condition was he was home and ok. No additional event or patient information is available.

Manufacturer Narrative

(b)(4).

Event Description

The complaint device was returned for evaluation. The device was visually inspected and no defect was found. Functional testing was performed and the reported fault could not be reproduced and there was no failure detected. A manual drop test for intermittency was performed and the test passed. A review of the downloaded data log observed that the receiver did not produce an audio alert during the date of issue. The reported event of an intermittent audio output was confirmed. A root cause could not be determined.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
• Type of Device: CONTINOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 6455615
• MDR Text Key: 71576526
• Report Number: 3004753838-2017-23455
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: MT22495-BLU
• Device Catalogue Number: STR-DR-BLU
• Device Lot Number: 5219358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3004753838-02/29/16-001C

Patient Treatment Data

Date Received: 04/03/2017 Patient Sequence Number: 1