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

Model Number 9500-44

Device Problems Imprecision (1307); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, there was an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter.Reportedly, calibrations were entered during periods of rapid rate of change.The sensor was inserted at the arm on (b)(6) 2018.No additional event or patient information is available.No data was provided for evaluation.The complaint confirmation of the reported inaccuracy could not be determined.A root cause could not be determined.Labeling indicates: do calibrate at least once every 12 hours.Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate and glucose alerts to become unreliable.This could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.Labeling indicates: do not calibrate if your blood glucose is changing at a significant rate, typically more than 2 mg/dl per minute.Do not calibrate when your receiver screen is showing the rising single arrow or double arrow, which indicates that your blood glucose is rising 2-3 mg/dl/min or more than 3 mg/dl/min.Also, do not calibrate when your receiver screen is showing the falling single arrow or double arrow, which indicates that your blood glucose is falling 2-3 mg/dl/min or more than 3 mg/dl/min.Calibrating during significant rise or fall of blood glucose may affect accuracy of sensor glucose readings.

• 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: 7640056
• MDR Text Key: 112606579
• Report Number: 3004753838-2018-69628
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/11/2018
• Device Model Number: 9500-44
• Device Catalogue Number: STS-GF-001
• Device Lot Number: 5232847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2017
• 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 Age: 8 YR