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

Model Number 9500-27

Device Problem Invalid Sensing (2293)

Patient Problem Coma (2417)

Event Date 02/03/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2017, the continuous glucose monitor (cgm) had inaccuracies compared to blood glucose (bg) meter in addition to an adverse event that occurred.The sensor was inserted in the patient's abdomen on (b)(6) 2017.The patient reported that cgm displayed value of 100mg/dl compared to bg meter value of 276mg/dl.The patient stated that he began to black out while driving on way to a movie theater.The patient stated that he had blacked out at movie theater and was administered glucophage tablets by a nurse who happened to be in the movie theater.The patient stated that his girlfriend drove to him to the hospital where they administered an iv and ab 50 to raise his blood sugar.The patient stated they began sternum rub as well.The patient stated that per the doctor's finger stick (fs) reading, his sugar was at 19mg/dl while cgm displayed 119mg/dl.This is after he was initially treated by the hospital and did his sugar raise to 19mg/dl.The patient stated that he was kept in hospital because of diabetic coma for 10 hours, until cleared.At time of contact the patient was well and back to normal.No additional event or patient information is available.Data log was reviewed for evaluation on (b)(6) 2017.Complaint for inaccuracy was confirmed.The root cause could not be determined post investigation.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING 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: 6375360
• MDR Text Key: 68964004
• Report Number: 3004753838-2017-15876
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)NI(17)NI
• 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: Other
• Type of Report: Initial
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 91