DEXCOM 4G TRANSMITTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-22 for DEXCOM 4G TRANSMITTER manufactured by Dexcom.

Event Text Entries

[18732247] In (b)(6), i reported to dexcom that i had a problem with my dexcom transmitter and receiver. I am diabetic. My blood sugar was extremely low and i had trouble walking. The dexcom did not alarm as it should have. I had to treat my low blood sugar. About 1/2 hour later, it finally alerted me that i had low blood sugar, but i had already treated it. I also told them that my alert signals that the dexcom could play would only vibrate. I tried every loud sounding option, but it would only vibrate. I called dexcom and they said they were going to report this to the fda. I am not sure if you received this complaint from them. They told me that i needed a new transmitter/receiver. However, after looking up my information, they told me that i had to go through the (b)(6). So i called the (b)(6). They told me that was not true. They said dexcom should replace it. They put me on hold for 1/2 hour, but i had to go back to work. I am not sure why they could not work this out without me. Dexcom and (b)(6) should have decided who would be sending me a new transmitter/receiver. This past (b)(6), i got extremely low at 3 am. I did not hear it because it only vibrated. My friend was with me and idd not hear it either. I tried to get up and fell and hit my head. At 7:15 am, my friend noticed that i was not waking up and there was something wrong. He poured 3 packs of sugar under my tongue. I finally started coming around and my blood sugar was 29. This means i was less than this for over 4 hours and i was not alerted because of a malfunctioning dexcom that should have been replaced. I could have died without my friend finding me like this. I also have a black eye from falling when i tried to get up.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5039294
MDR Report Key4284323
Date Received2014-11-22
Date of Report2014-11-22
Date of Event2014-11-22
Date Added to Maude2014-12-01
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameDEXCOM 4G TRANSMITTER
Generic NameTRANSMITTER
Product CodeDXH
Date Received2014-11-22
ID Number203-10LBL010785REV0
OperatorLAY USER/PATIENT
Device Sequence No1
Device Event Key0
ManufacturerDEXCOM

Device Sequence Number: 2

Brand NameDEXCOM 4G RECEIVER
Generic NameRECEIVER
Product CodeDXH
Date Received2014-11-22
OperatorLAY USER/PATIENT
Device Sequence No2
Device Event Key0
ManufacturerDEXCOM


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Required No Informationntervention; 3. Deathisabilit 2014-11-22

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