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U.S. Department of Health and Human Services


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Device Problems Nonstandard Device (1420); Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
People with diabetes know they have a dangerous situation, 24 hours/day for the rest of their lives. The nights are especially dangerous, if the person treats themselves and falls low when they are asleep and do not wake up. There are many variables each person with diabetes faces, including their intake of foods, fats, and proteins and the speed at which they breakdown to glucose in the blood. There are changes with activity and glucose can fall suddenly. If insulin is injected in a site that has become scarred, it will absorb poorly or to a new site, absorb more quickly. Blood testing done every few hours missed the direction of movement. The dexcom cgm has been an incredible device throughout the last 2 years. It has alerted us daily to highs and lows, to sudden changes. We would be lost without it! it is by far and away the best medical device available. It has no doubt saved lives. It also allows for saving limbs, hearts, eyes which would have been unknown hyperglycemias. Yes, the receivers are variable in their alarm function. Sometimes they work better at alarming, sometimes, they only vibrate. But, they are amazing still. People with diabetes have to use judgement all day long about how much insulin to inject, how much basal, how to eat, their exercise, blood testing. The cgm helps all the time. When the sensors become less functional, it is a judgement call, too. This is the life of a diabetic. The connection to the smartphones allows for redundancy and this can alarm loud! there is also a possible connection to a smart watch. So, there are visual, vibration, audible alerts (variable), smartphone alerts (loud) and watch alerts. I believe the class i recall is too much. Diabetes is a class i disease and we need all the help we can get.
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Manufacturer (Section D)
MDR Report Key5575979
MDR Text Key42769696
Report NumberMW5061668
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage