FDA Adverse Event Injury Summary report: N

SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

MDR report key: 3243896 · Received July 23, 2013

Report

Report Number
3004753838-2013-00197
Event Type
Injury
Date Received
July 23, 2013
Date of Event
June 25, 2013
Report Date
June 26, 2013
Manufacturer
DEXCOM, INC.
Product Code
MDS
PMA / PMN Number
P050012
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT THAT ON (B)(6) 2013, PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT. SHE DOES NOT RECALL SPECIFIC DETAILS ABOUT THE EVENT, BUT BELIEVES HER BG METER WAS READING APPROXIMATELY 70 MG/DL AND HER CGM WAS READING APPROXIMATELY 40 MG/DL AT THE TIME OF INCIDENT. PATIENT EXPRESSED CONCERN ABOUT THE DISCREPANCY BETWEEN HER BG METER AND CGM READINGS EVEN THOUGH CGM READING WAS LOWER. PATIENT BECAME ANXIOUS ABOUT HER LOW BLOOD SUGAR ON (B)(6) 2013 AND CALLED THE PARAMEDICS. WHILE WAITING FOR THE PARAMEDICS TO ARRIVE, SHE TREATED HERSELF WITH GLUCOSE. UPON ARRIVAL, PARAMEDICS TOOK PATIENT'S VITALS, AND PATIENT ASKED TO BE TRANSPORTED TO THE HOSPITAL. AFTER WAITING TO BEING ADMITTED, THE HOSPITAL STAFF TESTED PATIENT'S BLOOD SUGAR AT APPROXIMATELY 100 MG/DL. PATIENT WAS DISCHARGED FROM HOSPITAL. AT THE TIME OF HER CALL TO TECHNICAL SUPPORT, PATIENT REPORTED BEING IN FINE CONDITION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
344134 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-03 5065944

Patients

Seq Age Sex Outcome Treatment
1 60 YR Other