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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9500-27
Device Problems Use of Device Problem (1670); Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/12/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The g5 system is associated with product code pqf.
 
Event Description
Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017 the sensor wire was missing. The attempted sensor insertion was at the arm. 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: do not insert the sensor component of the dexcom g5 mobile system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years). The placement and insertion of the sensor component of the dexcom g5 mobile system is not approved for other sites. If placed in other areas, the dexcom g5 mobile system may not function properly.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint device was returned for evaluation. The device was visually inspected and confirmed customer complaint. Based on visual inspection, testing concluded that the sensor wire for (b)(4) is detached from the sensor pod and housing puck. The reported event of detached/missing sensor wire was confirmed. A root cause could not be determined.
 
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Brand NameDEXCOM G5 MOBILE 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 Key6544646
MDR Text Key74428579
Report Number3004753838-2017-38401
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 04/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2017
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 Number5211774
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/24/2017
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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