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

Model Number 9500-27

Device Problems Detachment Of Device Component (1104); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, after attempting to insert the sensor wire, it was noticed that it had detached and was located inside the applicator.The attempted sensor insertion was at the abdomen.No additional event or patient information is available.No product or data were provided for evaluation.The reported detached sensor wire could not be confirmed.A root cause could not be determined.

Manufacturer Narrative

(b)(4).Describe event or problem - correction to statement "dexcom was made aware on (b)(4) 2017 that on (b)(6) 2017, after attempting to insert the sensor wire, it was noticed that it had detached and was located inside the applicator.The attempted sensor insertion was at the abdomen.No additional event or patient information is available.No product or data were provided for evaluation.The reported detached sensor wire could not be confirmed.A root cause could not be determined.".

Event Description

Dexcom was made aware on (b)(4) 2017 that on (b)(6) 2017, after attempting to insert the sensor wire, it was noticed that the sensor wire was missing.The attempted sensor insertion was at the abdomen.No additional event or patient information is available.No product or data were provided for evaluation.The reported missing sensor wire could not be confirmed.A root cause could not be determined.The sensor wire was returned for evaluation.A visual inspection was performed and the sensor wire was missing from the sensor and the needle is safely retracted inside the applicator body.The customer complaint was confirmed.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: 6567399
• MDR Text Key: 75174402
• Report Number: 3004753838-2017-41866
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)5216036(17)170801
• 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: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2017
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: 5216036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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 Age: 73 YR
• Patient Weight: 82