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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 MDS

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS Back to Search Results
Model Number 9500-27
Device Problem Invalid Sensing (2293)
Patient Problems Bruise/Contusion (1754); Bone Fracture(s) (1870); Hypoglycemia (1912); Damage to Ligament(s) (1952)
Event Date 05/27/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia.
 
Event Description
Patient contacted dexcom on (b)(6) 2016 to report that they experienced continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter and an adverse event on (b)(6) 2016. The sensor was inserted into the abdomen on (b)(6) 2016. The patient stated that he was getting ready to go to work and his blood sugar was reading at 109mg/dl, per the cgm, but it was not correct. Patient's blood sugar was low, 41mg/dl, per a fingerstick reading. Patient stated that before he could get enough into his system to bring his blood sugar back to a safe number his legs gave out and he became incoherent. The patient rolled his ankle and severely bruised his side from trying to catch himself. The patient had to make a trip to the emergency room (er) for x-rays and glucose. The patient sustained torn ligaments and a small fracture in his foot. At the time of contact, the patient was bruised and had a brace. No additional event or patient information was provided.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceMDS
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 Key5750022
MDR Text Key48189253
Report Number3004753838-2016-38625
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 06/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2016
Is this an Adverse Event Report? Yes
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? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/25/2016 Patient Sequence Number: 1
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