MalfunctionNGB
A1CNOW SELFCHECK
Received May 15, 2014 · Event occurred Apr 1, 2014
Report 1826988-2014-00174 · MDR key 3812024
Device
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER RECEIVED A READING OF 8.9% ON HER A1CNOW MONITOR. THE READING SHE RECEIVED FROM HER DOCTOR'S A1C MONITOR WAS 7.1%. THE DIFFERENCES BETWEEN THE TWO COMPARISON TESTS COULD BE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE KIT IS EXPECTED TO BE RETURNED FOR EVALUATION. A NEW GLUCOSE MONITOR KIT WAS SENT.
Remedial action
- Replace