MAUDE Adverse Event Report: DEXCOM INC DEXCOM G6 CLARITY SOFTWARE; CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE

Model Number CLARITY SOFTWARE

Device Problem Loss of Data (2903)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2023

Event Type  malfunction  

Event Description

Had three month f/u appointment with endocrinology department this morning.Using dexcom g6 cgm, they indicate they have not received data through dexcom's clarity reporting software.

• Brand Name: DEXCOM G6 CLARITY SOFTWARE
• Type of Device: CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE
• Manufacturer (Section D): DEXCOM INC
• MDR Report Key: 17186465
• MDR Text Key: 317877759
• Report Number: MW5118713
• Device Sequence Number: 1
• Product Code: PHV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CLARITY SOFTWARE
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: MULTIPLE.
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White, American Indian Or Alaskan Native