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

Model Number 9500-27

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hypoglycemia (1912); Damage to Ligament(s) (1952); Seizures (2063)

Event Date 12/13/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient contacted dexcom on (b)(6) 2015 to report continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter and an adverse event that occurred on (b)(6) 2015.Sensor was inserted on (b)(6) 2015.At the time of the event, the cgm displayed a bg value of 130mg/dl and bg meter displayed 190mg/dl.Patient stated that she called for help as she started to have a seizure.The patient's neighbors called emt at approximately 8:00am est.Emt arrived, measured the patient's blood glucose level which was 42mg/dl.Patient was administered glucagon.Patient was admitted to er at approximately 10:30am, was administered 2 bags of fluids and had a blood test performed.The blood test showed that everything was fine.Additionally, patient had an mri of the knee performed for injury to her meniscus.At the time of contact, patient was still at the er and was having a cat scan performed to check for a concussion.Results of the cat scan were not available.Patient was recovering and reported that she will follow up with her regular doctor on (b)(6) 2015.No additional event information was provided.

Manufacturer Narrative

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

Event Description

Sensor was inserted on (b)(6) 2015.At the time of the event, the cgm displayed a bg value of 130mg/dl and bg meter displayed 90mg/dl.

• Brand Name: DEXCOM G4 PLATINUM 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: 5352376
• MDR Text Key: 35313050
• Report Number: 3004753838-2016-15307
• 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,Followup
• Report Date: 12/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• 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: 03/18/2016
• 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): Hospitalization
• Patient Age: 31 YR
• Patient Weight: 57