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

Model Number 9500-27

Device Problem Invalid Sensing (2293)

Patient Problems Hyperglycemia (1905); Nausea (1970); Vomiting (2144)

Event Date 04/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The g5 system is associated with product code pqf.Diabetes mellitus is a known cause of hyperglycemia and its associated effects.

Event Description

Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2017, the patient experienced continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter and a hyperglycemic event.The sensor was inserted into the abdomen on (b)(6) 2017.The patient was at work when they checked their cgm and it showed 126 mg/dl, but the patient felt their bg level was high.The patient began feeling sick and throwing up at work.The patient performed a finger stick and saw their bg level was 301 mg/dl, so the patient took insulin.There was no 3rd party intervention.The patient went home due to feeling nauseous and called dexcom about the inaccurate sensor.While on the phone, the patient did a calibration and the finger stick read 291 mg/dl while the cgm showed 291 mg/dl.At the time of contact, the patient was still feeling sick from high bg levels.No additional patient or event information is available.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 6564544
• MDR Text Key: 75067222
• Report Number: 3004753838-2017-26433
• 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: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2017
• 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 Outcome(s): Other
• Patient Age: 27 YR
• Patient Weight: 79