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

Model Number MT22495-BLU

Device Problem No Audible Alarm (1019)

Patient Problems Hypoglycemia (1912); Sweating (2444)

Event Date 10/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia.

Event Description

Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient experienced no audio output on the receiver and a hypoglycemic event.Date of issue is an approximation.The patient stated that while they were sleeping, they experienced a hypoglycemic event due to the receiver not alerting them.The patient stated that the receiver could have possibly been wrapped in the blankets.The patient woke up naturally, in a sweat and checked the receiver and it displayed low.The patient then checked their one touch and stated that the value was lower than 40 mg/dl.It was indicated that a little later, the receiver did vibrate an alert once the patient was showing a blood glucose value under 90 mg/dl.At the time of contact, the patient was in stable condition.No additional patient or event information is available.The receiver was returned for evaluation.An exterior visual inspection was performed, and the inspection passed.The receiver was charged and booted.A review of the downloaded receiver log observed a firmware error; however, it is unrelated to the customer complaint.Functional testing was performed, and the test failed.A manual "try it" functional test was performed, and the test failed.The receiver case was opened for further evaluation.An internal visual inspection was performed, and the inspection passed.The speaker resistance was measured, and the speaker resistance was out of specification.The reported event of no audio output was confirmed.The root cause was determined to be a defective speaker.

• 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: 7061683
• MDR Text Key: 93030254
• Report Number: 3004753838-2017-46642
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 30386270000171
• UDI-Public: 30386270000171
• 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: 11/03/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22495-BLU
• Device Catalogue Number: STR-DR-BLU
• Device Lot Number: 5210517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2017
• Initial Date FDA Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2016
• 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: 60 YR
• Patient Weight: 115