FDA Adverse Event Other Summary report: N

SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

MDR report key: 2273611 · Received September 9, 2011

Report

Report Number: 3004753838-2011-00272
Event Type: Other
Date Received: September 9, 2011
Date of Event: August 20, 2011
Report Date: August 20, 2011
Manufacturer: DEXCOM, INC.
Product Code: MDS
PMA / PMN Number: P050012
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEXCOM, INC AND FDA AGREED DURING A FACILITY INSPECTION THAT ANY POSSIBLE BROKEN SENSOR WIRE WAS A REPORTABLE EVENT, EVEN IN THE ABSENCE OF ANY EVIDENCE OF PHYSICAL HARM OR NECESSITY FOR INTERVENTION.

Description of Event or Problem · 1

PT CONTACTED DEXCOM TECH SUPPORT ON (B)(6) 2011 TO REPORT THAT, UPON REMOVAL OF SENSOR WIRE DUE TO SENSOR FAILURE PRIOR TO CALIBRATION, SHE NOTICED THAT NO WIRE WAS PRESENT. PT STATES THAT SHE HAS SCAR TISSUE AT THE SITE OF INSERTION AND THAT A WELT ALONG WITH SOME RED AND INFLAMED SKIN CAN BE OBSERVED. PT DOES NOT FEEL THAT SHE IS EXPERIENCING AN ALLERGIC REACTION BUT IS RATHER CONCERNED THAT SHE MAY HAVE A BROKEN SENSOR UNDER HER SKIN ALTHOUGH PT STATES THAT ALL SYMPTOMS SUBSIDE WITHIN A WEEK. AT THE TIME OF HER CALL TO DEXCOM TECH SUPPORT PT REPORTS FEELING NO CONCERN AND NO PAIN AT ALL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR		MDS	DEXCOM, INC.	9500-03	5014358

Patients

Seq	Age	Sex	Outcome	Treatment
1	38 YR		Other