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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Hypoglycemia (1912); Seizures (2063)

Event Date 05/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient contacted dexcom on (b)(6) 2016 to report that the patient experienced a hyperglycemic event on (b)(6) 2016 at 2:00 am. Patient stated that her service dog woke her up. Patient stated that she had a seizure and hit her head on her night stand when trying to stand up. Patient stated that her family drove her to the hospital which took 45 minutes to an hour. Patient stated that she was given an iv containing intravenous sugar solution. Patient stated that her blood glucose (bg) was at 35mg/dl when arriving at the hospital. Patient stated that she was released from the hospital in the early morning between 8:00-9:00 am. Patient reported that she had bruising on the side of her head, but experienced no further injuries. Patient stated that she was not using the continuous glucose monitor (cgm) at the time of the hypoglycemic event due to a shipping error with a replacement transmitter. At the time of contact, patient is healthy. No additional patient or event information was provided.

Manufacturer Narrative

(b)(4).

Event Description

Patient contacted dexcom on (b)(6) 2016 to report that the patient experienced a hypoglycemic event on (b)(6) 2016 at 2:00 am. Patient stated that her service dog woke her up. Patient stated that she had a seizure and hit her head on her night stand when trying to stand up. Patient stated that her family drove her to the hospital which took 45 minutes to an hour. Patient stated that she was given an iv containing intravenous sugar solution. Patient stated that her blood glucose (bg) was at 35mg/dl when arriving at the hospital. Patient stated that she was released from the hospital in the early morning between 8:00-9:00 am. Patient reported that she had bruising on the side of her head, but experienced no further injuries. Patient stated that she was not using the continuous glucose monitor (cgm) at the time of the hypoglycemic event due to a shipping error with a replacement transmitter. At the time of contact, patient is healthy. No additional patient or event information was provided.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• 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 ; 8585000200
• MDR Report Key: 5757065
• MDR Text Key: 48398396
• Report Number: 3004753838-2016-03629
• 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

• Type of Report: Initial,Followup
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/28/2016 Patient Sequence Number: 1