MAUDE Adverse Event Report: DEXCOM INC. DEXCOM CGM - FOLLOW APP; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FOR NON INTENSIVE DIABETES MANG

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2019

Event Type  malfunction  

Event Description

Dexcom follow app , when checking my son¿s blood sugar history to give an insulin correction, the history showed incorrect times associated with his sugar levels, causing it to appear less insulin was on board, causing too much insulin to be administered as a correction.Dexcom follow app.Choose the 6hr, 12hr, 24hr view.The times are incorrect and do not match the blood sugar history.Follow app - bug in update.

• Brand Name: DEXCOM CGM - FOLLOW APP
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FOR NON INTENSIVE DIABETES MANG
• Manufacturer (Section D): DEXCOM INC.
• MDR Report Key: 8392333
• MDR Text Key: 137995689
• Report Number: MW5084646
• Device Sequence Number: 1
• Product Code: QDK
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 12 YR
• Patient Weight: 45