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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

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM Back to Search Results
Model Number MT22495-BLU
Device Problem No Audible Alarm (1019)
Patient Problems Hyperglycemia (1905); Vomiting (2144)
Event Date 05/10/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hyperglycemia.
 
Event Description
Dexcom was made aware on (b)(6)2017 that on (b)(6)2017 the patient experienced a no audio alert and the next day on (b)(6)2017, a hyperglycemic event. Patient's mother reported that patient started vomiting on (b)(6)2017; the continuous glucose monitor (cgm) display value was "high" and the patient's ketone level was 4. 4 mmol/l. Patient was taken to the emergency room (er) by the parents on (b)(6)2017. Patient was treated with fluids and zofran. Blood work was also performed, but the results are not known. Patient was discharged on (b)(6)2017. Patient's mother alleges that she did not hear an alert from the receiver during the evening of (b)(6)2017. Additionally, the patient tested the receiver's alerts and it did not work. No further event or patient information is available. No product or data was provided for investigation. The reported issue could not be confirmed. The root cause could not be determined.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
Type of DeviceCONTINUOUS 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 Key6620249
MDR Text Key76942200
Report Number3004753838-2017-44729
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 05/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2017
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 Number5222067
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 Received05/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2016
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: 06/07/2017 Patient Sequence Number: 1
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