MAUDE Adverse Event Report: DEXCOM, INC.; MDS

Catalog Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hypoglycemia (1912); Overdose (1988)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient contacted dexcom on (b)(6) 2016, to report that the paramedics were called on (b)(6) 2016.Patient was not wearing dexcom continuous glucose monitor (cgm) at the time of the reported event.Patient was waiting for a shipment and it was taking some time with insurance.Patient reported that during this period, he experienced a low event of 42 mg/dl.Patient's wife called the paramedics.Patient was not transported to the hospital.Patient was fine after a bit of time.Patient reported that he had taken an extra unit of insulin prior to the reported event.At the time of contact, patient reported current condition as "good".No additional event or patient information is available.There was no alleged malfunction against the device.The complaint states that the patient experienced a low event on (b)(6) 2016.It should be noted that diabetes mellitus is a known cause of low blood glucose levels.

• Brand Name: NI
• 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: 5468473
• MDR Text Key: 39325704
• Report Number: 3004753838-2016-01353
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Public: (01)NI(241)NI(10)NI(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: Other
• Type of Report: Initial
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 78 YR