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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 MT22719
Device Problem No Audible Alarm (1019)
Patient Problem Seizures (2063)
Event Date 06/02/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient contacted dexcom on (b)(6) 2016 to report that they experienced no audio output from the receiver and an adverse event on (b)(6) 2016.The patient stated having a seizure due to her receiver not altering.A co-worker of the patient's called the paramedics.In addition, the nurse for the office was called down as well and the patient was given a glucagon shot with food to bring up her blood glucose (bg).The patient's bg values were at 32mg/dl before treatment was given and after the patient's bg was at 150mg/dl with the paramedics on site and checking.Patient was not transported to the hospital.At the time of contact, the patient was good.No additional event information was provided.
 
Manufacturer Narrative
(b)(4) if follow-up, what type?: additional information, correction/removal reporting number - additional.
 
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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 Key5767047
MDR Text Key48710892
Report Number3004753838-2016-38658
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000231
UDI-Public(01)00386270000231(241)MT22719(10)5205007(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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 06/08/2016
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 NumberMT22719
Device Catalogue NumberSTK-GF-001
Device Lot Number5205007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/08/2016
Initial Date FDA Received07/01/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/30/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/10/2015
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 Sequence Number1
Patient Outcome(s) Other;
Patient Age58 YR
Patient Weight101
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