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

Model Number 9500-35

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 08/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on 09/20/2018, that on (b)(6) 2018, a detached sensor wire was reported.The sensor was inserted into the arm on (b)(6) 2018.The patient stated upon removal of the sensor they threw out the sensor pod before realizing that the sensor wire was still in their arm.The patient had pain in his upper arm and went to the hospital on (b)(6) 2018 where he had an x-ray done that confirmed that the sensor wire was in his skin.The patient had the wire surgically removed.At the time of contact, the patient was doing fine.No additional patient or event information is available.No product was provided for investigation.Confirmation of the complaint was undetermined.The probable cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the initial mdr, additional information was provided.It was reported that the sensor was inserted into the arm and that the transmitter was not fully snapped in.Labeling indicates: sensor placement and insertion is not approved for sites other than the belly (abdomen).Labeling indicates: make sure you hear 2 clicks when you snap the transmitter in place.If it is not fully snapped in, this may lead to a poor connection and let fluids to get under the transmitter.This can lead to inaccurate sensor glucose readings.

Manufacturer Narrative

(b)(4).Correction to statements "dexcom was made aware on 09/20/2018, that on (b)(6) 2018, a detached sensor wire was reported." and "confirmation of the complaint was undetermined.".

Event Description

Dexcom was made aware on 09/20/2018, that on (b)(6) 2018, a detached sensor wire was reported.Confirmation of the allegation was confirmed based on the reported successful surgical extraction of the retained sensor wire on (b)(6) 2018.

• 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: 7980967
• MDR Text Key: 124291629
• Report Number: 3004753838-2018-126643
• 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: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/28/2018
• Device Model Number: 9500-35
• Device Catalogue Number: STS-GL-005
• Device Lot Number: 5230599
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2017
• 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 Outcome(s): Other
• Patient Age: 33 YR