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

Model Number MT22495-BLU

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

Patient Problems Fatigue (1849); Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient contacted dexcom on (b)(6) 2016, to report that she experienced a low event on (b)(6) 2016, resulting in medical intervention. Patient reported that she was wearing dexcom continuous glucose monitor (cgm) at the time of the event. Patient heard the low alarm from her cgm and took 2 glucose tablets. At last check prior to intervention, patient's cgm blood glucose (bg) reading was 55mg/dl and finger stick (fs) bg reading was 37mg/dl. Patient stated that she blacked out. Patient was at a hair solon when events occurred and an employee called paramedics due to the patient losing consciousness during the low event. Patient remembers waking up to an ambulance and her husband at the scene. Patient was given orange juice, but she threw it up. Paramedics/emergency medical technician's (emt) administered 50% dextrose (d50). Patient refused to be taken to the hospital. Patient reported that after intervention, her bg shot up to 301mg/dl around 1:30 pm. Patient took another fs around 2:15 pm, and reported that her bg reading dropped to 210 mg/dl. Patient reported that she takes medications. At the time of contact, the patient reported current condition as "feeling fatigued. " no additional event or patient information is available. There was no alleged device malfunction. It should be noted that diabetes mellitus is a known cause of hypoglycemia, resulting in loss of consciousness.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
• Type of Device: MDS
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego 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: 5404162
• MDR Text Key: 37303170
• Report Number: 3004753838-2016-00852
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000170
• UDI-Public: (01)00386270000170(241)MT22495-BLU(10)5206582(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

• Type of Report: Initial
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MT22495-BLU
• Device Catalogue Number: STK-DR-BLU
• Device Lot Number: 5206582
• 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: 01/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/02/2016 Patient Sequence Number: 1

Treatment

50 MG LOSARTIN (TWICE A DAY)