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

Model Number MT22495-BLU

Device Problem Defective Alarm (1014)

Patient Problems Hypoglycemia (1912); Sprain (2083); Concussion (2192); Injury (2348); Neck Pain (2433)

Event Date 05/17/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient contacted dexcom on (b)(6) 2016 to report that they experienced intermittent audio output and an adverse event on (b)(6) 2016.The patient was in a car wreck due to a low and the receiver's audio not going off.The paramedics treated the low on the scene with glucose tabs and juice boxes.Patient sustained a concussion, whiplash and a sprained wrist.The patient did not go to the hospital.Additionally, the patient tested the receiver's attentive and fixed low alerts and they worked.At the time of contact, the patient was okay.No additional event or patient information was provided.The complaint device was returned for evaluation.The device passed both internal and external visual inspection.There were no data log errors found that related to the complaint.Global receiver functional testing resulted in no failures related to the incident.The device passed the audio test, global communication tool software test and the drop test.The device also passed speaker resistance measurements.The reported fault could not be reproduced.The customer complaint could not be confirmed.A root cause could not be determined.

Manufacturer Narrative

(b)(4).

• 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: 5731162
• MDR Text Key: 47585973
• Report Number: 3004753838-2016-03458
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000170
• UDI-Public: (01)00386270000170(241)MT22495-BLU(10)5202781(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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22495-BLU
• Device Catalogue Number: STK-DR-BLU
• Device Lot Number: 5202781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3004753838-02/29/16-001C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 73