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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 Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/17/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(6) 2018, that on (b)(6) 2018, a missing sensor wire occurred. The sensor was inserted into the abdomen on (b)(6) 2018. No additional event or patient information is available. No product was provided for evaluation. The complaint confirmation was unable to be determined. A root cause could not be determined.
 
Manufacturer Narrative
Sr-(b)(4).
 
Event Description
A sensor was returned for evaluation. A visual inspection was performed and found that the sensor wire was missing. The customer's complaint of a missing sensor wire was 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 Key7351081
MDR Text Key102875671
Report Number3004753838-2018-27878
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup
Report Date 02/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/10/2018
Device Model Number9500-44
Device Catalogue NumberSTS-GF-001
Device Lot Number5231659
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2017
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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