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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM; MDS

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM; MDS Back to Search Results
Model Number 9438-06
Device Problem Wireless Communication Problem (3283)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 05/01/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).Diabetes mellitus is a known cause of hypoglycemia.
 
Event Description
Patient's mother contacted dexcom on (b)(6) 2016 to report that the patient experienced a loss of connection and an adverse event on (b)(6) 2016.Patient had a hypoglycemic event that lead to a seizure.Patient's mother called 911 at approximately 4:45 am.An ambulance and emergency medical technicians (emts) arrived within minutes and transported patient and patient's mother to the emergency room, where the patient was given an iv with fluids, zofran, and an anti-seizure medication.Patient was not as admitted to the hospital and stayed in the emergency room for observation until after 2:00 pm.At the time of contact, it was reported that the patient was exhausted and sore.No additional patient or event information is available.The complaint device was not returned for evaluation.However, the data log was provided by the patient.The data was reviewed on 05/20/2016 and did not confirm the reported loss of connection.A root cause could not be determined.
 
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Brand Name
DEXCOM G5 MOBILE 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 Key5681307
MDR Text Key45959398
Report Number3004753838-2016-03189
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000224
UDI-Public(01)00386270000224(241)9438-06(10)5208667(17)NI
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 Other
Type of Report Initial
Report Date 05/01/2016
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 Number9438-06
Device Catalogue NumberSTT-GF-001
Device Lot Number5208667
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/01/2016
Initial Date FDA Received05/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/13/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age8 YR
Patient Weight32
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