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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 MT22495
Device Problem Inappropriate or Unexpected Reset (2959)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/06/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the receiver initialized without a manual restart. No product or data was provided for evaluation. Confirmation of the allegation and a probable cause could not be determined. No injury or medical intervention was reported.
 
Manufacturer Narrative
(b)(4). Mfr 3004753838-2019-46418 was reported in error. Please disregard initial reporting of this event as this event has now been deemed non-reportable.
 
Event Description
Subsequent to the initial mdr, it was determined that a report was submitted in error. Upon further review, it was determined that the patient allegation does not meet the criteria of a reportable event.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
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 Key8667827
MDR Text Key147079747
Report Number3004753838-2019-046418
Device Sequence Number1
Product Code MDS
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 06/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22495
Device Catalogue NumberSTK-DR-001
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 Received06/06/2019
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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