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

Device Problem Imprecision (1307)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 09/20/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient experienced an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter and an adverse event.It was reported that the reading on the cgm indicated that the patient was not low and did not alarm, which resulted in the patient experiencing a hypoglycemic event and a seizure.Further event details were not provided; however, it was indicated that the patient is no longer using the dexcom device.No additional patient or event information is available.No data was provided for evaluation.The reported event of inaccuracies could not be confirmed.A root cause could not be 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: 6959388
• MDR Text Key: 89647474
• Report Number: 3004753838-2017-68891
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 10/18/2017
• 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 Outcome(s): Other