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

Model Number MT22495

Device Problem No Audible Alarm (1019)

Patient Problems Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418)

Event Date 08/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia and its associated effects.

Event Description

Dexcom was made aware on (b)(6) 2016 that the patient experienced no audio output from the receiver and an adverse event on (b)(6) 2016.Patient's wife reported that they did not hear the receiver alerts or alarms when the patient's glucose levels dropped quickly.She stated that she found him having a seizure at approximately 11:00 pm while he was sleeping.Patient's wife used 1 1/2 shots of the glucagon on him and he regained consciousness.She reported that his glucose levels were high before he went to sleep (186mg/dl-190mg/dl) and that he must have dropped very quickly.She stated that he doesn't experience seizures unless he's in the 20's but she did not know for sure what his glucose levels were.At the time of contact, the patient was healthy.No further patient information is available.The complaint device was provided for investigation.The device was determined to be in good condition based on external visual inspection.Review of log data did not find any errors related to the customer complaint.Global receiver functional testing resulted in audio failures.The reported event of no audio output was confirmed.The root cause was determined to be a defective speaker assembly.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE 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: 5933342
• MDR Text Key: 54097177
• Report Number: 3004753838-2016-80273
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000156
• UDI-Public: (01)00386270000156(241)MT22495(10)5214939(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
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22495
• Device Catalogue Number: STR-DR-001
• Device Lot Number: 5214939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2016
• 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
• Treatment: BUPROPION HCL; FENOFIBRATE TABLETS; FLUTICASONE PROP NASAL; INSULIN; LANTUS; LIPITOR; NOVOCAINE; OMEGA 3 ACID; SPIRIVA
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 86