V-GO DISPOSABLE INSULIN DELIVERY DEVICE
Received Sep 18, 2014 · Event occurred Dec 2, 2013
Report 1226572-2014-00010 · MDR key 4115801
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
58 YR
- Death
Narrative
Additional Manufacturer Narrative
THIS MDR IS BEING SUBMITTED FOLLOWING OUR PROCEDURE: PT EXPIRED (REPORTABLE EVENT) WHILE ON THE V-GO; DEVICE UNAVAILABLE FOR INVESTIGATION; INSUFFICIENT INFO AVAILABLE TO EXPLAIN IF V-GO CONTRIBUTED TO THE EVENT OR NOT.
Description of Event or Problem
IT WAS REPORTED TO VALERITAS CUSTOMER CARE DURING AN INBOUND CALL ON (B)(6) 2014 TO THE PT'S WIFE WHO HAD JUST STARTED ON THE V-GO THAT HER HUSBAND WHO HAD ALSO BEEN ON THE V-GO HAD PASSED AWAY ON (B)(6) 2013. PT WAS A TYPE 2 DIABETIC AND WAS ON THE V-GO 40 FOR 4 MONTHS PRIOR TO PASSING AWAY. SHE DID NOT INDICATE THE CAUSE OF DEATH. PT'S WIFE DECLINED TO OFFER FURTHER INFO TO VALERITAS CUSTOMER CARE. IT IS UNK IF THE V-GO OR DIABETES WAS INVOLVED IN THIS PT'S DEATH. IT IS NOT POSSIBLE TO ASSESS CONTRIBUTORY FACTORS TO THIS PT'S DEATH WITHOUT FURTHER DETAILS AND INFO. THE ADVERSE EVENT ASSESSOR MADE MULTIPLE ATTEMPTS TO CONTACT THE PT'S FAMILY TO FURTHER INVESTIGATE. RESULTS HAVE NOT BEEN FRUITFUL.