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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 MDS

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS Back to Search Results
Model Number MT22495-BLU
Device Problem No Audible Alarm (1019)
Patient Problems Hypoglycemia (1912); Lethargy (2560)
Event Date 01/01/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia.
 
Event Description
Patient contacted dexcom on 04/21/2016 to report that they experienced no audio output and an adverse event on (b)(6) 2016. The patient had a missed low due to the receiver not alarming. He was feeling sluggish and his wife had to get him some juice. The patient recovered after having some juice. Additionally, the patient tested the receiver's audio function and it did not beep. No additional event or patient information was provided.
 
Manufacturer Narrative
(b)(4).
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE 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 Key5665412
MDR Text Key45469185
Report Number3004753838-2016-03117
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 04/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2016
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 Number5197933
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/05/2015
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 Treatment Data
Date Received: 05/18/2016 Patient Sequence Number: 1
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