G6 TRANSMITTER FOR CONTINUOUS GLUCOSE MONITORING SYSTEM STT-OR-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-01 for G6 TRANSMITTER FOR CONTINUOUS GLUCOSE MONITORING SYSTEM STT-OR-001 manufactured by Dexcom.

MAUDE Entry Details

• Report Number: MW5090129
• MDR Report Key: 9145150
• Date Received: 2019-10-01
• Date of Report: 2019-09-28
• Date of Event: 2019-09-10
• Date Added to Maude: 2019-10-02
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: G6 TRANSMITTER FOR CONTINUOUS GLUCOSE MONITORING SYSTEM
• Generic Name: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MGMT
• Product Code: QDK
• Date Received: 2019-10-01
• Model Number: G6
• Catalog Number: STT-OR-001
• Lot Number: 5260141
• Device Expiration Date: 2019-09-27
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEXCOM

Device Sequence Number: 2

• Brand Name: G6 TRANSMITTER FOR CONTINUOUS GLUCOSE MONITORING SYSTEM
• Generic Name: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MGMT
• Product Code: QDK
• Date Received: 2019-10-01
• Model Number: G6
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: DEXCOM

Device Sequence Number: 3

• Brand Name: G6 TRANSMITTER FOR CONTINUOUS GLUCOSE MONITORING SYSTEM
• Generic Name: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MGMT
• Product Code: QDK
• Date Received: 2019-10-01
• Model Number: G6
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: DEXCOM

Device Sequence Number: 4

• Brand Name: G6 TRANSMITTER FOR CONTINUOUS GLUCOSE MONITORING SYSTEM
• Generic Name: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MGMT
• Product Code: QDK
• Date Received: 2019-10-01
• Model Number: G6
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: DEXCOM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Deathisabilit	2019-10-01