MAUDE Adverse Event Report: DEXCOM, INC.; MDS

Catalog Number UNKNOWN

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

Patient Problems Hyperglycemia (1905); Urinary Tract Infection (2120); Vomiting (2144)

Event Date 06/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hyperglycemia and its associated effects.

Event Description

Patient's caregiver contacted dexcom on (b)(6) 2106 to report that the patient experienced an adverse event on (b)(6) 2016.At the time of contact, the patient was in the hospital due to having a bladder infection, dehydration and throwing up.It was reported that the symptoms did not arise from wearing the dexcom continuous glucose monitor (cgm) but rather, was due to the patient experiencing high blood glucose.It was further stated that the dexcom cgm did not malfunction.Patient's caregiver stated that as of (b)(6) 2016, the patient was doing well.No additional event or patient information was provided.No product or data was returned for evaluation.The reported event could not be confirmed.A root cause could not be determined.

• Brand Name: NA
• Type of Device: MDS
• 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: 5804411
• MDR Text Key: 49879055
• Report Number: 3004753838-2016-38815
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• 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: 06/22/2016
• 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: 79 YR