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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
Model Number 9500-27
Device Problem Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/26/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018, there was a reported missing sensor wire. The sensor was inserted into the abdomen on (b)(6) 2018. The device has been received for investigation. A follow-up will be submitted upon completion of device investigation. Confirmation of the problem and probable cause could not be determined. No additional event or patient information is available.
 
Manufacturer Narrative
(b)(4).
 
Event Description
A sensor was returned for evaluation. A visual inspection was performed and found that the sensor wire is missing from the sensor pod and seal carrier. The reported event of a missing or detached wire was confirmed. A probable cause could not be determined.
 
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Brand NameNI
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key7349254
MDR Text Key102813686
Report Number3004753838-2018-027812
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000019
UDI-Public00386270000019
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
Type of Report Initial,Followup
Report Date 02/26/2018
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 Model Number9500-27
Device Catalogue NumberSTS-GL-011
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2018
Was Device Evaluated by Manufacturer? Yes
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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