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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 9500-27
Device Problems Use of Device Problem (1670); Component Missing (2306)
Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)
Event Date 07/13/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017 the sensor wire was missing. Additionally, the patient stated that the sensor wire issue included pain at the insertion site. The attempted sensor insertion was at the upper buttocks on (b)(6) 2017. No medical intervention was reported. No additional event or patient information is available. No product or data were provided for evaluation. The reported missing sensor wire could not be confirmed. A root cause could not be determined. Labeling indicates: sensor placement and insertion is not approved for sites other than the belly (abdomen).
 
Manufacturer Narrative
(b)(4).
 
Event Description
A sensor was returned for evaluation. A visual inspection was performed and found that the wire is missing. The customer's complaint of a missing sensor wire was confirmed. A root cause could not be determined.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
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 Key6761050
MDR Text Key81626368
Report Number3004753838-2017-59812
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 07/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2017
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
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/30/2017
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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