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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

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9438-06
Device Problem Wireless Communication Problem (3283)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 02/23/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).The g5 system is associated with product code pqf.Diabetes mellitus is a known cause of seizures.
 
Event Description
Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, the patient experienced a seizure.Patient's wife found patient in bed experiencing a seizure.Patient's wife called emergency medical services (ems).Ems arrived and treated patient with glucose.Patient's blood glucose (bg) was at approximately 40 mg/dl.Patient was not admitted to hospital.Patient's wife alleges that the patient went low and did not received an alert due to signal loss.At the time of contact, patient was stable.No additional patient or event information was provided.Data was provided for evaluation.The reported loss of connection was confirmed via data.A root cause could not be determined.
 
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Brand Name
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING 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 Key6509122
MDR Text Key73327066
Report Number3004753838-2017-26401
Device Sequence Number1
Product Code MDS
UDI-Device Identifier10386270000221
UDI-Public(01)10386270000221(241)STT-GF-001(10)6000846(15)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 03/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2017
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 Number6000846
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2016
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 Age64 YR
Patient Weight100
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