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

Model Number 9500-27

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

Patient Problems Bruise/Contusion (1754); Fall (1848); Hypoglycemia (1912)

Event Date 10/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia.

Event Description

Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient experienced continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter and an adverse event.The sensor was inserted into the abdomen on (b)(6) 2016.The patient reported that they were low when the cgm was displaying 120mg/dl.Patient indicated that she had a fingerstick value of somewhere in the 30's.The patient fell down due to the low, took a glucose tab and went home after she waited a few minutes.The patient had a slight bruise on her face due to the fall.The patient was not taken to the hospital and the paramedics were not called.Additionally, the patient reported that throughout the day, the sensor was off by the following points: 31, 32, 101, 404, 71, 40 and 36.The patient also took medication containing acetaminophen.At the time of contact, the patient was doing well.Additional event or patient information is not available.No product or data was provided for evaluation.The reported event of cgm inaccuracy was not confirmed.A root cause could not be determined.Labeling indicates: taking medications with acetaminophen (such as (b)(6) extra strength) while wearing the sensor may falsely raise your sensor glucose readings.The level of inaccuracy depends on the amount of acetaminophen active in your body and is different for each person.

• 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: 6082518
• MDR Text Key: 59279710
• Report Number: 3004753838-2016-80799
• Device Sequence Number: 1
• Product Code: MDS
• 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: P120005
• 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: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 10/12/2016
• 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 Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 57