MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM; MDS

Model Number MT22495-PNK

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

Patient Problems Bruise/Contusion (1754); Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 03/30/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient contacted dexcom on (b)(6) 2016 to report an adverse event that occurred on (b)(6) 2016.The patient, who works at a hospital, passed out and was taken to the emergency room (er).The patient was treated in the er with d50, an iv and a glucagon shot.The patient sustained bruising of the arm due to er administering shot.Pt was released from the er the same day.At the time of contact, the patient was fine.There was no alleged device malfunction.No additional event or patient information was provided.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING 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: 5636123
• MDR Text Key: 44550698
• Report Number: 3004753838-2016-02877
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000163
• UDI-Public: (01)00386270000163(241)MT22495-PNK(10)5198555(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: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• 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: STR-DR-PNK
• Device Lot Number: 5198555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2015
• 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: 53 YR
• Patient Weight: 66