MAUDE Adverse Event Report: DEXCOM, INC.; CONTINUOUS GLUCOSE MONITOR

Catalog Number UNKNOWN

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

Patient Problem Hypoglycemia (1912)

Event Date 11/24/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Similar adverse event is being reported under mfr 3004753838-2018-162965.

Event Description

Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the patient experienced a hypoglycemic episode.It is unclear if the dexcom system caused or contributed to the event.The patient¿s husband stated that the patient¿s endocrinologists needs the patient¿s glucose readings.No additional patient or event information is available.

• Brand Name: NI
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 8200737
• MDR Text Key: 131540601
• Report Number: 3004753838-2018-162967
• 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: Other
• Type of Report: Initial
• Report Date: 11/28/2018

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 77 YR