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

Model Number 9500-45

Device Problem Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(64 2018, that on (b)(6) 2018, a detached sensor wire was reported.The sensor was inserted into the abdomen on (b)(6) 2018.It was reported that upon removal of the sensor, the sensor wire remained under the patient's skin.It was indicated that on (b)(6) 2018, the patient visited a healthcare facility and the surgeon was able to feel the sensor wire in the skin and surgically removed the sensor wire.No symptoms or injury were reported.At the time of contact, the patient was doing good.No additional patient or event information is available.No product was provided for evaluation.The complaint confirmation was unable to be determined.A root 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 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: 7611109
• MDR Text Key: 111390261
• Report Number: 3004753838-2018-65981
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2018
• Device Model Number: 9500-45
• Device Catalogue Number: STS-GF-004
• Device Lot Number: 5229818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other
• Patient Age: 5 YR