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

Model Number 9500-44

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient experienced a missing sensor wire.The sensor was inserted into the abdomen on (b)(6) 2017.The patient reported that the sensor pod fell off at night and there was no sensor wire visible.Patient reported that there was nothing in their body.Product was not provided for evaluation.Confirmation of the reported issue and a root cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

A sensor was returned for evaluation.A visual inspection was performed and found that the wire is missing from the sensor pod.The customer's complaint of a missing/detached sensor wire was confirmed.A root cause could not be determined.

Manufacturer Narrative

(b)(4).

• Brand Name: DEXCOM G4 PLATINUM 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: 7103194
• MDR Text Key: 94420490
• Report Number: 3004753838-2017-103020
• Device Sequence Number: 1
• Product Code: MDS
• 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,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/14/2018
• Device Model Number: 9500-44
• Device Catalogue Number: STS-GF-001
• Device Lot Number: 5226693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 69 YR
• Patient Weight: 80