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

Model Number MT20649-1

Device Problem Unexpected Shutdown (4019)

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

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the patient experienced an adverse event.The patient's niece stated the patient was in the garden while wearing the cgm (continuous glucose monitor) but it did not alarm.He then went back inside of his house around 3:00pm.After about 1.5 hours, the neighbor and caregiver found the patient on the floor unconscious, with severe bruises all over his body and small lacerations, especially on his head.Paramedics were called and the patient was taken to a clinic where he stayed overnight.While at the hospital, a ct scan (computed tomography scan) was performed which found no issues.Additionally, the patient's prosthesis was damaged as a result of the hypoglycemic event.It was unknown if the prosthesis was damaged during or after the fall.At the time of the event, it was reported that the device did not have any icons or values being displayed.At the time of last contact, the patient was in stable condition.No additional patient or event information is available.No data or product was provided for evaluation.The complaint confirmation was unable to be determined.A root cause was not determined.

Manufacturer Narrative

Sr-(b)(4).

Event Description

The complaint receiver device was returned for evaluation.The device was externally visually inspected and no defects were found.The receiver was able to be charged and rebooted.The receiver log was downloaded, the data contains no issues related to complaint.Functional testing was performed and it passed.The receiver case was opened and the internal inspection passed.The reported event of unexpected receiver shutdown was not confirmed.The root cause could not be determined.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS 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: 7810619
• MDR Text Key: 118040110
• Report Number: 3004753838-2018-95584
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 07/25/2018

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: MT20649-1
• Device Catalogue Number: STK-GL-010
• Device Lot Number: 5233565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2018
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 08/23/2018
• Supplement Dates Manufacturer Received: 10/04/2018
• Supplement Dates FDA Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 73 YR
• Patient Weight: 65