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

Model Number 9500-27

Device Problem Invalid Sensing (2293)

Patient Problems Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418)

Event Date 05/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of loss of consciousness, hypoglycemia and its associated effects.

Event Description

Patient contacted dexcom on 05/09/2016 to report that they experienced continuous glucose monitoring (cgm) inaccuracies and an adverse event on (b)(6) 2016.The sensor was inserted into the thigh on (b)(6) 2016.Patient stated that they had a seizure immediately after doing a blood glucose (bg) check at 12:12 pm.The patient had eaten at 9:30 am and used an extended bolus.Patient stated that at 12:12 pm the bg meter was reading 40mg/dl but cgm read 61mg/dl.Patient was trying to calculate how many carbohydrates to eat to increase their bg.The next thing they remember was that 15 minutes later they were on the bathroom floor, after the patient's wife administered 2 bottles of liquid glucose (30 grams).Patient stated that it was too much glucose but they were able to get their bg down to an almost acceptable level of 142mg/dl by bedtime.Patient was not taken to the hospital.At the time of contact, the patient was in good condition.No additional event or patient information was provided.Data was available for review.However, date range for data did not cover the date of event.The reported complaint of cgm inaccuracies could not be confirmed.A root cause was not determined.Additionally, the sensor was inserted into the thigh.The dexcom g5 cgm system user's guide states: do not insert the sensor component of the dexcom g5 mobile system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years).The placement and insertion of the sensor component of the dexcom g5 mobile system is not approved for other sites.If placed in other areas, the dexcom g5 mobile system may not function properly.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• 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: 5699419
• MDR Text Key: 46559904
• Report Number: 3004753838-2016-03307
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)5207640(17)161227
• 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: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/27/2016
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: 5207640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2015
• 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: 72 YR
• Patient Weight: 79