MAUDE Adverse Event Report: DEXCOM, INC. T:SLIM G4 SYSTEM; CONTINUOUS GLUCOSE MONITOR

Model Number 9500-27

Device Problems Use of Device Problem (1670); Invalid Sensing (2293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, there was an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter.The sensor was inserted at the arm on (b)(6) 2017.Reportedly, the patient used more than one bg meter during their sensor session.No additional event or patient information is available.No data was provided for evaluation.The reported inaccuracy could not be confirmed.A root cause could not be determined.Labeling indicates: do not insert the sensor in sites other than the abdomen (belly) or upper buttocks (for ages 12-17 only).Other sites have not been studied and are not approved.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.Labeling indicates: finger stick bg values will vary from meter to meter, and test to test.It is important that the patient use the same commercially distributed bg meter during their session.

• Brand Name: T:SLIM G4 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: 6788289
• MDR Text Key: 82897394
• Report Number: 3004753838-2017-41465
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)NI(17)NI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2017
• 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 Age: 46 YR
• Patient Weight: 77