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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. CONTINUOUS GLUCOSE MONITOR

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DEXCOM, INC. CONTINUOUS GLUCOSE MONITOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Hypoglycemia (1912); Loss of consciousness (2418); Confusion/ Disorientation (2553)
Event Date 10/06/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4) diabetes mellitus is a known cause of hypoglycemia and its associated effects.
 
Event Description
Dexcom was made aware on 10/07/2016, that on (b)(6) 2016, the patient experienced a diabetic low that required intervention from paramedics. The patient reported that she was at 183mg/dl when she had last checked her blood glucose (bg) meter and 20 minutes later she started feeling very sleepy and could not think. The patient used her life alert meter and passed out. The patient's husband heard the life alert, picked up the patient and administered juice. The ambulance came and the paramedics tested the patient's bg, which was 109mg/dl. The patient declined hospitalization. At the time of the event, the patient was not wearing the continuous glucose monitoring (cgm) system as she had not yet received her replacement equipment due to backorder. At the time of contact, the patient was stable. Additional event or patient information is not available. No product or data was provided for evaluation. The reported low event could not be confirmed. A root cause could not be determined.
 
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Brand NameNI
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 Key6072501
MDR Text Key58985599
Report Number3004753838-2016-80778
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 10/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received10/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/02/2016 Patient Sequence Number: 1
Treatment
AIRBORNE; ATERVASTATION; CITALOPRAM; COQ10; FEIRSOL; HUMALOG U100; HUMILIAN 7030; LIFE ALERT; VITAMIN D2
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