V-GO DISPOSABLE INSULIN DELIVERY DEVICE

Additional Manufacturer Narrative

PROCEDURE REQUIRES FILING AND MDR BASED ON THE FOLLOWING INFORMATION: CASES INVOLVING KETOACIDOSIS UNLESS THERE IS A CLEAR EXPLANATION NOT INVOLVING THE DEVICE. THREE DEVICES WERE RETURNED FOR INVESTIGATION. ALL THREE DEVICES SHOW NO EVIDENCE OF MALFUNCTION. THERE IS EVIDENCE THAT THE DEVICES HAD INSULIN IN THEM ALTHOUGH IT COULD NOT BE DETERMINED WHETHER THE DEVICES HAD BEEN COMPLETELY FILLED WITH INSULIN. THEREFORE, THERE WAS NO CLEAR EXPLANATION FOR THE DKA. SEE SCANNED PAGES.

Description of Event or Problem

DIABETIC PATIENT TYPE 1 PER PT. ON V-GO 30 USING NOVOLOG REPORTED TO VALERITAS CUSTOMER CARE (VCC) HIGH BLOOD GLUCOSE READINGS AND WAS REPORTEDLY HOSPITALIZED IN ICU FOR 4 DAYS. THE PT. INDICATED HE WAS INITIALLY SWITCHED FROM THE VGO 20 TO THE VGO 30 BECAUSE HE WAS EXPERIENCING HYPERGLYCEMIA. THE PT'S AIC TEST WAS AROUND 7 PERCENT PRE-V-GO AND ROSE TO 9 PERCENT HE REPORTED IN J(B)(6) WHILE USING THE V-GO. THE PT REPORTED HE WAS HOSPITALIZED WITH A DIAGNOSIS OF DIABETIC KETOACIDOSIS (DKA) ON (B)(6) 2014 AND RELEASED ON (B)(6) 2014. BLOOD GLUCOSE HAD RISEN TO 500-600S. HE WAS READMITTED (B)(6) 2014 AND AGAIN RELEASED ON (B)(6) 2014. BLOOD GLUCOSE HAD RISEN TO THE 400'S. THE PATIENT REPORTED TO VALERITAS ADVERSE EVENT ASSESSOR THAT THE GRAY INDICATOR ON THE V-GOS HWE USED HAD MOVED AS FAR AS POSSIBLE INDICATING THE INSULIN WAS DELIVERED BY THE VGO. THE PT. HAD EXPERIENCED VOMITING AND FEELING POORLY. HIS WHITE BLOOD COUNT WAS 19,000 BUT THE HOSPITAL TESTS COULD NOT FIND ANY INFECTION HIS WIFE INDICATED. THE PT'S HEALTH CARE PROVIDER INDICATED TO THE PT. THE ONLY EXPLANATION THEY HAD FOR THE HYPERGLYCEMIA AND DKA WAS THE VGO WAS NOT DELIVERING INSULIN.