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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 Foreign Body In Patient (2687)
Event Date 08/30/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on 08/31/2016, that on (b)(6) 2016, the patient experienced a detached sensor wire. The sensor was inserted into the arm on (b)(6) 2016. Patient's mother reported that upon sensor pod removal no sensor wire was visible from the underside of the sensor pod. The sensor wire was not visible through the skin, and the insertion site was describe as having palpable bump. Patient's mother reported that the sensor was functioning as normal for 9 days then suddenly failed. Dexcom representative advised mother that the sensor should not be worn for more than 7 days. Patient's mother reported that the patient was in urgent care being seen about the missing sensor wire. At the time of contact patient is good. No additional patient or event information was provided. The sensor was inserted into the arm. Labeling indicates: do not insert the sensor in sites other than the belly (abdomen) or upper buttocks. Use in other sites might cause sensor glucose readings to be inaccurate and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
 
Manufacturer Narrative
(b)(4).
 
Event Description
A sensor (serial number (b)(4)/ lot 5209805) was returned for evaluation; however, it cannot be determined if this is the device at fault. A visual inspection was performed and found that the wire is missing from the sensor pod and housing puck. Due to the missing sensor wire, the sensor wire is considered detached. The customer's complaint of a 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 Key5977840
MDR Text Key55621980
Report Number3004753838-2016-62371
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000019
UDI-Public(01)00386270000019(241)9500-27(10)5211758(17)170512
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 08/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/12/2017
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5211758
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/12/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/26/2016 Patient Sequence Number: 1
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