MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM RECEIVER WITH SHARE; SENSOR, GLUCOSE, INVASIVE

Device Problem Device Alarm System (1012)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 03/07/2018

Event Type  Injury  

Event Description

Dexcom sent me a defective receiver that did not alarm as it should for hypoglycemia and hyperglycemia.I reported this to them, but they did not file an adverse reaction report with the fda and wouldn't accept a return of the defective receiver.

• Brand Name: DEXCOM G4 PLATINUM RECEIVER WITH SHARE
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 7637901
• MDR Text Key: 112487303
• Report Number: MW5078060
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Disability
• Patient Age: 38 YR
• Patient Weight: 63