FDA Adverse Event Injury Summary report: N

NOVA MAX PLUS GLUCOMETER

MDR report key: 6108915 · Received November 15, 2016

Report

Report Number
MW5066088
Event Type
Injury
Date Received
November 15, 2016
Date of Event
January 1, 2014
Report Date
November 15, 2016
Manufacturer
NOVA DIABETES CARE
Product Code
NBW
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

REPORTER STATES THAT IN THE YEAR 2014 HE BEGAN USING THE NOVA MAX PLUS GLUCOMETER AND IMMEDIATELY BEGAN RECEIVING INACCURATE READINGS EITHER TOO HIGH OR TOO LOW. WHILE IN THE CLINIC HE WAS INSTRUCTED HOW TO USE THE DEVICE. UPON USING IT HIS FIRST GLUCOSE READING WAS 300, UNSURE OF ITS ACCURACY, HE TESTED IT AGAIN AND RECEIVED A READING OF 100. HE HAS GONE BACK TO COMPLAIN AND HAS BEEN GIVEN A NEW GLUCOMETER EACH TIME. HE IS CURRENTLY USING HIS THIRD ONE. HE WAS TOLD THAT THE ISSUE MAY HAVE BEEN WITH THE TEST STRIPS BUT SINCE THEN HE HAS BEEN USING A NUMBER OF DIFFERENT TEST STRIPS BUT THE SAME ISSUE OF INACCURATE READINGS STILL PERSIST. HE STATES THAT THE DIABETIC CLINIC IS AWARE OF THIS ISSUE BECAUSE IT HAS HAPPENED TO OTHER PEOPLE AND THE CLINIC HAS REPORTED IT TO THE MANUFACTURER. HE GOES ON TO SAY THAT WHEN HE CONTACTED THE MANUFACTURER THEY CLAIM THAT THEY HAVE NOT RECEIVED ANY ISSUE REPORTS. UPON USING THIS DEVICE HE HAS BEEN IMPROPERLY MANAGING HIS GLUCOSE LEVELS CAUSING HIM TO HAVE EPISODES OF SYNCOPE, DIAPHORESIS, TREMORS AND CYANOSIS OF HIS LIPS. HE GOES ON TO SAY THAT HE MAY HAVE HAD POSSIBLE STROKES AND HEART ATTACKS BUT IS UNSURE. HE IS UNABLE TO GO TO THE HOSPITAL DUE TO HIS LACK OF INSURANCE. HE PLANS TO PURSUE LEGAL ACTION AGAINST THE MANUFACTURER AND TO CONTACT HIS CHANNEL (B)(6) NEWS ABOUT THIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
755609 NOVA MAX PLUS GLUCOMETER NOVA MAX PLUS GLUCOMETER NBW NOVA DIABETES CARE

Patients

Seq Age Sex Outcome Treatment
1 58 YR Life Threatening