FDA Adverse Event Injury Summary report: N

DEXCOM G4 PLATINUM SENSOR

MDR report key: 5191383 · Received October 21, 2015

Report

Report Number
MW5057563
Event Type
Injury
Date Received
October 21, 2015
Date of Event
October 15, 2015
Report Date
October 21, 2015
Manufacturer
DEXCOM
Product Code
MDS
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I'M A TYPE 1 DIABETIC AND I'VE BEEN WEARING THE DEXCOM G5 FOR A FEW MONTHS TO HELP MONITOR MY CONTINUOUS BLOOD SUGAR. IT HAS BEEN REALLY HELPFUL AND HAS BROUGHT DOWN MY A1C QUITE SUBSTANTIALLY. HOWEVER, LAST THURSDAY, (B)(6) WHEN I WAS CHANGING SENSORS I RAN INTO A PROBLEM. I INSERTED THE SENSOR INTO MY LOWER ABDOMINAL AREA AND WAITED FOR THE TRANSMITTER TO READ. THE TRANSMITTER DIDN'T READ SO I EVENTUALLY TOOK THE SENSOR OFF THINKING PERHAPS THE TUBING WITH NEEDLE INSIDE WAS KINKED. WHEN I TOOK THE SENSOR OFF, THE TUBING WAS NO LONGER ATTACHED TO THE SENSOR AND I COULD STILL FEEL IT UNDER THE SKIN. I ATTEMPTED TO SEE IF IT COULD BE REMOVED WITH TWEEZERS BUT THAT WAS IMPOSSIBLE, IT WAS UNDERNEATH THE SKIN. I WASN'T SURE WHAT I SHOULD DO SO I WAITED TO SEE HOW I FELT. I EVENTUALLY ENDED UP AT URGENT CARE THE FOLLOWING DAY BECAUSE I WAS GETTING SHARP PAINS IN THE ABDOMEN WHERE SENSOR HAD BEEN INSERTED. LONG STORY SHORT, THEY CUT ME OPEN TO LOCATE THE MISSING TUBE BUT TO NO AVAIL. THE TUBE WAS TOO SMALL AND BASICALLY COLORLESS. EXTREMELY HARD TO RETRIEVE. I NOW HAVE STITCHES AND THE TUBING IS STILL SOMEWHERE IN MY BODY CAUSING SHARP ABDOMINAL PAINS INTERMITTENTLY. I CALLED AND SPOKE WITH A DEXCOM REPRESENTATIVE ON FRIDAY, (B)(6) TO MAKE NOTE OF THE SITUATION. HE WAS APOLOGETIC, ASKED QUESTIONS AND I BELIEVE TOOK NOTES. I WANTED TO INFORM SOMEONE THAT THIS HAD HAPPENED AND THAT IT SHOULD BE DISCUSSED WITH THE MANUFACTURER. I ALSO WANTED TO SEE WHAT THE COMPANY RECOMMEND I DO IN THIS SITUATION. I HAVE ANOTHER DOCTOR APPOINTMENT SCHEDULED FOR THIS WEEK. I'M NOT SURE WHAT WILL BE DISCUSSED BUT I DO HOPE TO ALLEVIATE THIS ABDOMINAL PAIN SOONER THAN LATER. I'M CURIOUS IF THIS TYPE OF THING EVER HAPPENED BEFORE? IF SO, WHAT WAS THE SOLUTION? I CAN'T IMAGING LEAVING IT INSIDE OF MY BODY TO CAUSE RANDOM SHOOTING PAINS. THE SENSOR WAS A DEXCOM G4 PLATINUM SENSOR, REF. (B)(4), LOT 5202454, (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
697707 DEXCOM G4 PLATINUM SENSOR DEXCOM PLATINUM SENSOR MDS DEXCOM 9500-27 5202454

Patients

Seq Age Sex Outcome Treatment
1 39 YR Required Intervention