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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

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9500-44
Device Problem Detachment Of Device Component (1104)
Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Event Date 06/12/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2017 that on (b)(6) 2017, after attempting to insert the sensor wire, it was noticed that it had detached and was stuck in the insertion site. Additionally, the patient stated that the sensor wire issue included pain and bleeding at the insertion site. The sensor was inserted at the abdomen on (b)(6) 2017. No medical intervention was reported. No additional event or patient information is available. No product or data were provided for evaluation. The reported detached sensor wire could not be confirmed. A root cause could not be determined.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING 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 Key6686361
MDR Text Key79058799
Report Number3004753838-2017-45243
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial
Report Date 06/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-44
Device Catalogue NumberSTS-GF-007
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 Received06/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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