MAUDE Adverse Event Report: DEXCOM, INC.; CONTINUOUS GLUCOSE MONITOR

Catalog Number STS-GS-003

Device Problem Imprecision (1307)

Patient Problems Hypoglycemia (1912); Dizziness (2194); Sweating (2444)

Event Date 10/31/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter occurred.The sensor was inserted into the abdomen on (b)(6) 2020.The patient was at home and experienced sweating and dizziness during the night.The cgm at the time was displaying 400 mg/dl.The bg reading was taken twice, and the value was under 40 mg/dl.The patient¿s daughter removed the sensor and called the emergency doctor.Glucagon was given at the patient¿s home by the emergency doctor.The patient was then taken to the hospital for standard checks (reportedly based on the patient being elderly).She went home with her husband and daughter after a short period of time.At the time of the report she was at home and in good condition.No data was provided for evaluation.Confirmation of the allegation and a probable cause could not be determined.The reported glucose values fall within the e zone of the parkes error grid.No additional patient or event information is available.

• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: ashley spoto ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 10878743
• MDR Text Key: 217618190
• Report Number: 3004753838-2020-141299
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: STS-GS-003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• 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: 80 YR