FDA.reportPublic FDA data

MAUDE MDR 4115801

MDR report key
4115801
Report number
1226572-2014-00010
Event key
0
Event type
3
Date of event
2013-12-02
Date received
2014-09-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
SCOTT HUIE
Address
800 BOSTON TURNPIKE SHREWSBURY MA 01545 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1V-GO DISPOSABLE INSULIN DELIVERY DEVICEV-GOVALERITAS, INC.KZEV-GO 40UNKR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-09-1801. D

Event Narratives#

D

Patient 1

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.

N

Patient 1

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.

N

Patient 1