MAUDE Adverse Event Report: DEXCOM CONTINUOUS GLUCOSE MONITOR

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/12/2016

Event Type  Injury  

Event Description

Using a dexcom cgm for uncontrolled type 1 diabetes mellitus, the sensor wire detached and remained in the leg (upper thigh).

• Brand Name: CONTINUOUS GLUCOSE MONITOR
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM
• MDR Report Key: 5761343
• MDR Text Key: 48642496
• Report Number: MW5063166
• Device Sequence Number: 1
• Product Code: MDS
• 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: 06/27/2016

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR
• Patient Weight: 79