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U.S. Department of Health and Human Services

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

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DEXCOM, INC. UNKNOWN CONTINUOUS GLUCOSE MONITOR Back to Search Results
Device Problem Imprecision (1307)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The patient experienced adverse events on different days with the same device. The following reports are being submitted: (b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, there was an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter. The sensor was inserted on (b)(6) 2018. No additional event or patient information is available. No product or data was provided for evaluation. The complaint confirmation of the reported inaccuracy could not be determined. A root cause could not be determined.
 
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Brand NameUNKNOWN
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 Key8187761
MDR Text Key131198436
Report Number3004753838-2018-159973
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 12/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2018
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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