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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 12/25/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on (b)(4) 2018, via social media, that on (b)(6) 2016, the patient experienced low blood glucose that resulted in a seizure.The patient's mother indicated that the patient spent christmas in the emergency room.It was unable to be determined if the patient was wearing the dexcom at the time of event.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.

• Brand Name: NI
• 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: 7221054
• MDR Text Key: 98431522
• Report Number: 3004753838-2018-09380
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7 YR