MAUDE Adverse Event Report: DEXCOM DEXCOM 5 TRANSMITTER; CONTINUOUS GLUCOSE MONITOR

Device Problem Calibration Problem (2890)

Patient Problem Hypoglycemia (1912)

Event Date 12/05/2017

Event Type  Injury  

Event Description

My (b)(6) son is a newly diagnosed type 1 diabetic.We were very excited to get approved for a dexcom because we wanted him to be as independent as possible but we certainly wanted to be able to monitor his bsg from a safe parental distance.The dexcom was applied on (b)(6).All went well on the (b)(6) and (b)(6).On the (b)(6) we noticed that he would have a low, we would then ask him to eat carbs and then he would be high.That was very uncharacteristic.Eventually, we started having him check is bsg on his hand held glucometer and we realized that the dexcom readings were not in synch.We recalibrated 5-6 times per day.After 24 hours of this we changed the sensor to a new sensor.Similar happenings occurred.One time dexcom said my son was over 400 and he was only 167.Another time it woke us up for a critical low value.We woke him up out of his sleep and he was fine on his hand held glucometer.We tried to reach dexcom on (b)(6) and there was greater than a 30 minute wait.We tried again on the (b)(6) and we spoke with 3 representatives who would all blame the same problems: your son is on tylenol, your son has scar tissue, the sensor came out, the sensor is bad.My son does not take tylenol.My son does not have scar tissue, this is a new diagnoses for him.We have tried multiple sensors.The only thing that makes sense is that the transmitter is bad.However, dexcom insists that there is no evidence that there is a bad transmitter despite all evidence pointing otherwise.We cannot keep this product on my child because if he listens to it, he will be eating carbs despite the fact that he is not actually low (and we did this and then had to give him insulin).When the product says he is high, we give insulin and he becomes low.This product is a danger to his health and we, as parents, were willing to try another transmitter but dexcom refuses to believe that there is a problem with their product and they continually tell me there is a problem with my child.They refuse to send a replacement despite the obvious health issues that this product produces.I threw it in the garbage.Buyer beware.You might kill yourself if you calculate your insulin or carbs off of this product.

• Brand Name: DEXCOM 5 TRANSMITTER
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM
• MDR Report Key: 7120646
• MDR Text Key: 95081776
• Report Number: MW5073977
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/03/2017
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 41