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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. CONTINUOUS GLUCOSE MONITOR

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DEXCOM, INC. CONTINUOUS GLUCOSE MONITOR Back to Search Results
Catalog Number UNKNOWN
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/27/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the device ran 14-24 points lower than the one touch ultra glucometer. No additional event or patient information is available. No product or data was provided for evaluation. The complaint confirmation could not be determined. A root cause could not be determined.
 
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Brand NameNI
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 Key7630646
MDR Text Key112187459
Report Number3004753838-2018-68402
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 05/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/27/2018
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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