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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 MDS

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS Back to Search Results
Model Number MT20649
Device Problem No Audible Alarm (1019)
Patient Problem Seizures (2063)
Event Date 04/07/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient contacted dexcom on 06/16/2016 to report that they experienced intermittent audio output from the receiver and an adverse event on (b)(6) 2016. The patient stated that she did not hear low alert and went into a diabetic seizure. The patient called and had ambulance come pick her up. The paramedics administered glucagon. When the patient arrived at emergency room she was given an iv with glucose and food. At the time of contact, the patient was doing well. Additionally, the patient tested the receiver's high alert and it sounded. No further event information was provided. Complaint device was returned for evaluation. A visual exterior inspection was performed on the receiver and found no observations related to the customer complaint. Data was downloaded from the receiver and reviewed, this resulted in no failures related to customer complaint. A global receiver functional test was performed on the receiver and it resulted in no failures related to customer complaint. The reported fault of intermittent audio output could not be reproduced. The complaint of intermittent audio output could not be confirmed. The root cause could not be determined.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceMDS
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 Key5800082
MDR Text Key49740083
Report Number3004753838-2016-38682
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
Report Date 06/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649
Device Catalogue NumberSTK-GL-001
Device Lot Number5196088
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2014
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: 07/16/2016 Patient Sequence Number: 1
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