MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM; MDS

Model Number MT22495-PNK

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

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 02/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient contacted dexcom on (b)(4) 2016 to report an adverse event that occurred on (b)(6) 2016.Patient stated that they felt dizzy and fell down.Patient did not have low blood glucose (bg) and thought their bg was fall around 150mg/dl at the time.Patient was taken to the hospital by ambulance and treated for the fall.Insulin was also used in the general treatment of the patient while at the hospital.Patient sustained bruising.There was no alleged device malfunction.No additional event or patient information was provided.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
• 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: 5527869
• MDR Text Key: 41209834
• Report Number: 3004753838-2016-02115
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000163
• UDI-Public: (01)00386270000163(241)MT22495-PNK(10)5204319(17)NA
• 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: 02/26/2016

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: MT22495-PNK
• Device Catalogue Number: STK-DR-PNK
• Device Lot Number: 5204319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/26/2016
• Initial Date FDA Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 57 YR
• Patient Weight: 104