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

Model Number 9500-27

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

Patient Problem Foreign Body In Patient (2687)

Event Date 08/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on 08/31/2016, that on (b)(6) 2016, the patient experienced a detached sensor wire.The sensor was inserted into the arm on (b)(6) 2016.Patient's mother reported that upon sensor pod removal no sensor wire was visible from the underside of the sensor pod.The sensor wire was not visible through the skin, and the insertion site was describe as having palpable bump.Patient's mother reported that the sensor was functioning as normal for 9 days then suddenly failed.Dexcom representative advised mother that the sensor should not be worn for more than 7 days.Patient's mother reported that the patient was in urgent care being seen about the missing sensor wire.At the time of contact patient is good.No additional patient or event information was provided.The sensor was inserted into the arm.Labeling indicates: do not insert the sensor in sites other than the belly (abdomen) or upper buttocks.Use in other sites might cause sensor glucose readings to be inaccurate and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

Manufacturer Narrative

(b)(4).

Event Description

A sensor (serial number (b)(4)/ lot 5209805) was returned for evaluation; however, it cannot be determined if this is the device at fault.A visual inspection was performed and found that the wire is missing from the sensor pod and housing puck.Due to the missing sensor wire, the sensor wire is considered detached.The customer's complaint of a missing sensor wire was 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: 5977840
• MDR Text Key: 55621980
• Report Number: 3004753838-2016-62371
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)5211758(17)170512
• 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: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/12/2017
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: 5211758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2016
• 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: 11 YR
• Patient Weight: 38