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

Model Number MT22719

Device Problem Device Stops Intermittently (1599)

Patient Problems Hypoglycemia (1912); Dysphasia (2195)

Event Date 12/26/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient's husband contacted dexcom on (b)(6) 2015 to claim intermittent audio output on (b)(6) 2015.It was reported that the patient experienced a hypoglycemic event where she became incoherent.Paramedics were called and transported patient to the hospital.Patient had a finger stick reading of 33mg/dl and was given dextrose intravenously.No additional even 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 device was determined to be operating within the required specifications without malfunction.The reported event of an intermittent audio output was not confirmed.A root cause could not be determined.

• 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: 5384547
• MDR Text Key: 36585634
• Report Number: 3004753838-2016-05286
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000231
• UDI-Public: (01)00386270000231(241)MT22719(10)5204647(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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22719
• Device Catalogue Number: STK-GF-001
• Device Lot Number: 5204647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2015
• 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): Other
• Patient Age: 33 YR
• Patient Weight: 95