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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM CONTINOUS GLUCOSE MONITOR Back to Search Results
Model Number MT22495-BLU
Device Problem Defective Alarm (1014)
Patient Problems Fall (1848); Hypoglycemia (1912); Seizures (2063)
Event Date 03/09/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia.
 
Event Description
Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2017, the patient experienced intermittent audio output on the receiver, in addition to an adverse event that occurred. The patient stated that on (b)(6) 2017 he had woke up about 5:35am, continuous glucose monitor (cgm) showed 87mg/dl, with a diagonal down arrow. The patient's blood glucose (bg) meter tested at that time at 103mg/dl and the patient reports dosing a basal insulin. The patient's cgm was under 50mg/dl at 6:15am, then went down to 37mg/dl. The patient stated the cgm receiver vibrated but did not give audible alert. The patient stated that he does not remember after that. The patient stated that he had a seizure and fell on his side. The patient's partner gave the patient glucagon, orange juice, and a peanut butter sandwich. The patient's bg readings went up to 105mg/dl, then the patient's partner took the patient to the doctor's office where he was cared for by a nurse practitioner. The patient had a shoulder x-ray performed, and they checked the patient's tongue, side, and head for trauma. The patient was prescribed hydrocodone for pain, and a new glucagon prescription. The patient was told to take alieve for inflammation, and to gargle with salt water for tongue injury. At time of contact the patient's condition was he was home and ok. No additional event or patient information is available.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint device was returned for evaluation. The device was visually inspected and no defect was found. Functional testing was performed and the reported fault could not be reproduced and there was no failure detected. A manual drop test for intermittency was performed and the test passed. A review of the downloaded data log observed that the receiver did not produce an audio alert during the date of issue. The reported event of an intermittent audio output was confirmed. A root cause could not be determined.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
Type of DeviceCONTINOUS 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 Key6455615
MDR Text Key71576526
Report Number3004753838-2017-23455
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22495-BLU
Device Catalogue NumberSTR-DR-BLU
Device Lot Number5219358
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number3004753838-02/29/16-001C

Patient Treatment Data
Date Received: 04/03/2017 Patient Sequence Number: 1
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