MalfunctionNGB
A1CNOW SELFCHECK
Received Jan 27, 2014 · Event occurred Jan 1, 2014
Report 1826988-2014-00017 · MDR key 3593824
Device
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER RECEIVED A READING OF 4.7% ON THE A1CNOW KIT. HIS READING IN THE LAB WAS 5.7%. THE DIFFERENCE BETWEEN THE TESTS COULD BE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. PRODUCT IS NOT EXPECTED TO BE RETURNED. A NEW BLOOD GLUCOSE TESTING KIT WAS SENT TO THE CUSTOMER.
Remedial action
- Replace