MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number MT20649-2

Device Problem Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on 02/25/2019 that on (b)(6) 2019 the receiver shutdown unexpectedly.No additional event or patient information is available.No product was provided for evaluation.The complaint confirmation of the receiver ceasing to function could not be determined.A root cause could not be determined.

Manufacturer Narrative

(b)(4).Describe event or problem -correction "dexcom was made aware on 02/25/2019 that on (b)(6)2019 the receiver shutdown unexpectedly.The complaint confirmation of the receiver ceasing to function could not be determined.".

Event Description

Dexcom was made aware on 02/25/2019 that on (b)(4)2019 the receiver initialized without manual restart.The complaint confirmation of initializing screen without manual restart could not be determined.

Manufacturer Narrative

(b)(4).Mfr (b)(4) was reported in error.Please disregard initial reporting of this event as this event has now been deemed non-reportable.B5: describe event or problem - additional.H2: additional information.

Event Description

Subsequent to the initial mdr, it was determined that a report was submitted in error.Upon further review, it was determined that the patient allegation does not meet the criteria of a reportable event.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego, ca CA 92121
• MDR Report Key: 8449998
• MDR Text Key: 140154649
• Report Number: 3004753838-2019-29032
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT20649-2
• Device Catalogue Number: STK-GL-117
• Device Lot Number: 5241414
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1