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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Blood Loss (2597)
Event Date 10/25/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(6) 2016 that on (b)(6) 2016, the patient experienced an adverse event. The sensor was inserted at the abdomen on (b)(6) 2016. Patient reported that she had taken a shower before she noticed blood on her clothing. A nurse came to assist her, and told the patient that the sensor had to come off. Patient reported that the nurse applied pressure to the insertion for 20 minutes, then applied a pressure band-aid. Nurse instructed patient to leave the band-aid on until the next day, and also not to insert a sensor until the next day. Patient reported that the nurse mentioned that patient lost about a pint of blood and is anemic. At the time of contact patient was weak. No additional patient or event information was provided. No product or data was provided for evaluation. The customer complaint could not be 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 Key6114827
MDR Text Key60413630
Report Number3004753838-2016-52767
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
Report Date 10/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5214810
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 Received10/25/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/03/2016
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: 11/18/2016 Patient Sequence Number: 1
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