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

Model Number 9500-44

Device Problem Imprecision (1307)

Patient Problems Hypoglycemia (1912); Weakness (2145); Shaking/Tremors (2515)

Event Date 01/12/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on (b)(4) 2019 that on (b)(6) 2019, there was an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter and a hypoglycemic event.The sensor was inserted into the abdomen.The patient stated during the day the cgm was displaying 150 mg/dl.He started feeling symptoms of hypoglycemia where his hands were shaking, and his legs felt weak.He took a bg reading which displayed 45 mg/dl and dosed himself with dextrose tablets.After treating himself with the tablets, he felt better.At the time of contact, the patient was doing okay.No data was provided for evaluation.The complaint confirmation and root cause could not be determined.The reported glucose values fall within the d zone of the parkes error grid.No additional event or patient information is available.

• 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: 8350107
• MDR Text Key: 136486746
• Report Number: 3004753838-2019-19303
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9500-44
• Device Catalogue Number: STS-GF-001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2019
• 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: 49 YR