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

Model Number MT20649-PNK

Device Problem Defective Alarm (1014)

Patient Problems Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418)

Event Date 03/31/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient contacted dexcom on (b)(6) 2016 to report that they experienced intermittent audio output and a hypoglycemic event on (b)(6) 2016.The patient stated that they went for a walk in the morning and then returned home and took a nap.Before the patient fell asleep, she saw a blood glucose (bg) value within her target range (between 70 mg/dl and 180 mg/dl).The patient went to sleep and her husband returned home to find the patient having a seizure and unconscious.The patient's husband checked her continuous glucose monitor (cgm) which read 44mg/dl but there was no audible alert.The patient's husband treated the patient with glucagon and she regained consciousness.At the time of contact, the patient was fine.Additionally, patient tested the receiver and it did make an audible sound.No additional event or patient information was reported.The complaint device was returned for evaluation.A follow-up report will be submitted upon its completion.

Manufacturer Narrative

(b)(4) describe event or problem - additional, device available for evaluation - additional, additional information/device evaluation, device evaluated by manufacturer - additional, event problem and evaluation codes - additional.

Event Description

The complaint device being used at the time of event was returned for evaluation.A exterior visual inspection was performed and no defects were found.Functional testing was performed and failed audio.A review of the downloaded data log did not find any errors related to the customer complaint.The receiver case was opened for further evaluation.An interior inspection found a foreign substance on the speaker diaphragm.The reported event of no audio output was confirmed.The root cause was determined to be a defective speaker assembly.

• Brand Name: DEXCOM G4 PLATINUM 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: 5621599
• MDR Text Key: 44114756
• Report Number: 3004753838-2016-02624
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000088
• UDI-Public: (01)00386270000088(241)MT20649-PNK(10)5178454(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: Notification
• Type of Report: Initial,Followup
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT20649-PNK
• Device Catalogue Number: STR-GL-PNK
• Device Lot Number: 5178454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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): Other
• Patient Age: 53 YR
• Patient Weight: 96