V-GO DISPOSABLE INSULIN DELIVERY DEVICE
Received Oct 23, 2014 · Event occurred Oct 7, 2014
Report 1226572-2014-00014 · MDR key 4203707
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
59 YR
- Hypoglycemia
Narrative
Description of Event or Problem
IT WAS REPORTED TO VALERITAS CUSTOMER CARE BY TYPE 2 DIABETIC PT THAT HE HAD EXPERIENCED HYPOGLYCEMIC EVENTS WITH THE LOWEST BLOOD GLUCOSE READING OF 17 WHILE USING THE V-GO. PT HAS BEEN USING V-GO THERAPY FOR ONE YEAR. HCP HAS CHANGED THE PT FROM V-GO 30 TO V-GO 40. PT STATED THAT THERE WERE TIMES OF LOW BG READINGS WHERE HE SELF MEDICATED BY EATING PEANUT BUTTER, MILK, AND ORANGE JUICE. PT ALSO STATED "HE HAS HAD LOW READINGS OF 17-24-25-27-33 AND HE SAID WHEN IT WAS 17 AND 24 HIS WIFE CALLED 911 AND HE CAME AWARE WHEN HE WAS IN AN AMBULANCE WITH "POLICE AROUND HIM". PT HAS ALSO STATED THAT HIS HCP IS AWARE OF THESE INCIDENTS. VALERITAS AE ASSESSORS HAVE TRIED TO CONTACT THE PT TO INVESTIGATE FURTHER, WITHOUT SUCCESS. VALERITAS PRODUCT COMPLIANCE HAS SENT A LETTER TO THE PT REQUESTING CONTACT INFO, VIA (B)(6).
Additional Manufacturer Narrative
THIS MDR IS BEING SUBMITTED FOLLOWING OUR PROCEDURE: PT REPORTED HYPOGLYCEMIC EVENT WITH BG READING AS LOW AS 17 WHICH REQUIRED THIRD PARTY INTERVENTION TO TREAT; DEVICE UNAVAILABLE FOR INVESTIGATION; INSUFFICIENT INFO AVAILABLE TO EXPLAIN IF V-GO CONTRIBUTED TO THE EVENT OR NOT.