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

Model Number 9438-05

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

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

Event Date 11/06/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Patient contacted dexcom on (b)(6) 2015 to report that on (b)(6) 2015, patient experienced an intermittent out of range signal.The complaint device was not returned for evaluation.However, the data log was provided by the patient.The data was reviewed on (b)(6) 2015 and confirmed the reported event of intermittent antenna icon.A definitive root cause could not be determined.No additional patient or event information is available.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 5257655
• MDR Text Key: 32489950
• Report Number: 3004753838-2015-63477
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000125
• UDI-Public: 00386270000125
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9438-05
• Device Catalogue Number: STT-RX-001
• Device Lot Number: 5194726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 82