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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 STS-JP-004
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/11/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a broken needle occurred. The sensor was inserted into the abdomen on (b)(6) 2020. No product was provided for evaluation. Confirmation of the allegation and a probable cause could not be determined. No injury or medical intervention was reported.
 
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Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
ashley spoto
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key10864684
MDR Text Key218234947
Report Number3004753838-2020-139857
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 11/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSTS-JP-004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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