MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM SENSOR; SENSOR, GLUCOSE, INVASIVE

Device Problem Device Sensing Problem (2917)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 05/17/2022

Event Type  Injury  

Event Description

Ppt was without dexcom sensor and experienced adverse events since he could not use his insulin pump which is not functional without sensor, ppt had to use injection.Ppt had high and low "bs," 50 to 450.Fda safety report id# (b)(4).

• Brand Name: DEXCOM SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 14457231
• MDR Text Key: 292354936
• Report Number: MW5109801
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: INSULIN PUMP
• Patient Age: 50 YR
• Patient Sex: Male