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

Model Number MT20649-PNK

Device Problem No Audible Alarm (1019)

Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908)

Event Date 03/03/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient contacted dexcom on (b)(6) 2016 to report that they experienced no audio output from the receiver and an adverse event on (b)(6) 2016.The patient had high blood sugar as a result of the receiver not alarming.When the patient's blood sugar would not go down, she went to the hospital.The patient was admitted for high blood sugar as well as high blood pressure and stayed there for two days.The patient could not recall what treatment was administered but stated it was some kind of anti-biotic and something to relax, such as valium.Additionally, the patient tested the receiver's audio function and it did not beep.No further event or patient information is available.

Manufacturer Narrative

(b)(4) if follow-up, what type?: additional information, correction/removal reporting number - additional.

• 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: 5684140
• MDR Text Key: 46060695
• Report Number: 3004753838-2016-60349
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000088
• UDI-Public: (01)00386270000088(241)MT20649-PNK(10)5188584(17)NA
• 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,Followup
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT20649-PNK
• Device Catalogue Number: STK-RX-PNK
• Device Lot Number: 5188584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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): Hospitalization; Other
• Patient Age: 68 YR
• Patient Weight: 54