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

Model Number 9500-27

Device Problems Use of Device Problem (1670); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018, there was a reported missing sensor wire.The sensor was inserted into the arm on (b)(6) 2018.The device has been received for investigation.A follow-up will be submitted upon completion of device investigation.The transmitter was removed prior to the removal of the sensor pod.Confirmation of the problem and probable cause could not be determined.Labeling indicates: sensor placement and insertion is not approved for sites other than the belly (abdomen).No additional event or patient information is available.Labeling indicates: do not remove the transmitter while the sensor pod is still attached to the body.Labeling indicates: sensor placement and insertion is not approved for sites other than the belly (abdomen).No additional event or patient information is available.

Manufacturer Narrative

(b)(4).

Event Description

A sensor was returned for evaluation.A visual inspection was performed and found that the sensor wire is missing from the sensor pod and seal carrier.The reported event of a missing or detached wire was confirmed.A probable cause could not be determined.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 7323600
• MDR Text Key: 102105710
• Report Number: 3004753838-2018-023803
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: 00386270000019
• 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
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/19/2018
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: 5229717
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/27/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 82