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

Model Number MT20649

Device Problem Defective Alarm (1014)

Patient Problems Bruise/Contusion (1754); Fall (1848); Loss of consciousness (2418)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on 06/17/2017, that on (b)(6) 2017, the patient experienced no audio alert and an adverse event.The patient reported that they were at home and checked their continuous glucose monitor (cgm) device and it read 37mg/dl.The patient did not hear any alerts and passed out before they could do anything to correct their low.The patient's daughter called the paramedics.It was indicated that the paramedics administered the patient with intravenous (iv) therapy for glucose.The paramedics transported the patient to a medical facility.The patient was treated by a physician.The details of the treatment are unknown.The patient was released from the medical facility the same day.Additionally, the patient reported that he fell and has a bruise on his back.At the time of event, the patient had recovered from the incident.No additional patient or event information is available.The receiver was returned for evaluation.A visual inspection as performed and no defects were found.Functional testing was performed and the test passed.A drop test for intermittency was performed and the test passed.A review of the downloaded data log did not find any errors related to the customer complaint.The reported event of an intermittent audio output was not confirmed.A root cause could not be determined.

• 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 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: 6690002
• MDR Text Key: 79175448
• Report Number: 3004753838-2017-57813
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10386270000061
• UDI-Public: (01)10386270000061(241)STK-GL-001(10)5191732(17)SM41667230
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT20649
• Device Catalogue Number: STK-GL-001
• Device Lot Number: 5191732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3004753838-02/29/16-001C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 89