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

Model Number MT22495

Device Problem Defective Alarm (1014)

Patient Problems Fall (1848); Hypoglycemia (1912)

Event Date 01/26/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on 03/17/2017, that on (b)(6) 2017, the patient experienced intermittent audio output on the receiver, in addition to an adverse event that occurred.The patient stated that she was home alone when she had a low and fell on the tile floor and busted her eye open.The patient stated that she is not sure how long she was out but when her husband came home he found her unconscious on the floor and called the paramedics.The paramedics gave her two dextrose injections but she was still taking a while to respond so her husband and the husband told the paramedics to take her to the hospital.At the hospital the patient was given glucose gel and a glucagon shot, she also received stitches in her eye.The patient stated that she was then released from the hospital after a long while.The patient alleges the event was caused because the alarms did not alert her.At time of contact the patient's condition was good.No additional event or patient information is available.The device has been received for evaluation.  a follow-up report will be submitted once the evaluation is complete.

Manufacturer Narrative

(b)(4).

Event Description

The complaint device was returned for evaluation.The device was visually inspected and no defect was found.Functional testing was performed and the reported fault could not be reproduced and there was no failure detected.A review of the downloaded receiver log did not find any errors related to the customer complaint.A manual drop test for intermittency was performed and the test passed.The case was opened for internal inspection and passed.The reported event of an intermittent audio output was not confirmed.A root cause could not be determined.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
• Type of Device: CONTINOUS GLUCOSE MONITOR
• 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: 6488931
• MDR Text Key: 72652832
• Report Number: 3004753838-2017-26289
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 20386270000150
• UDI-Public: (01)20386270000150(241)STK-RR-001(10)5201374(15)NI
• Combination Product (y/n): N
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22495
• Device Catalogue Number: STK-RR-001
• Device Lot Number: 5201374
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/11/2017
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2015
• 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: 59 YR
• Patient Weight: 59