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

Model Number MT22719-PNK

Device Problem No Audible Alarm (1019)

Patient Problem Injury (2348)

Event Date 09/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient experienced no audio output from the receiver and an adverse event.It was indicated that medical intervention was required but no details were provided.Additionally, the patient tested the receiver and it did not beep.No further event or patient information is available.The receiver was returned for evaluation.A follow-up will be submitted upon completion of device investigation.

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.The device was determined to be operating within the required specifications without malfunction.The reported event of no audio output was not confirmed.A root cause could not be determined.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS 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: 6153564
• MDR Text Key: 61695068
• Report Number: 3004753838-2016-88450
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000262
• UDI-Public: (01)00386270000262(241)MT22719-PNK(10)5215855(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: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22719-PNK
• Device Catalogue Number: STK-GF-PNK
• Device Lot Number: 5215855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• 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: 33 YR