MalfunctionNGB
A1CNOW SELFCHECK
Received Oct 11, 2013 · Event occurred Sep 5, 2013
Report 1826988-2013-00489 · MDR key 3710191
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A BAYER REPRESENTATIVE FROM CANADA REPORTED THAT A PHARMACIST RAN AN A1CNOW TEST ON A CUSTOMER WITH A RESULT OF 9.7%. PREVIOUSLY, THE CUSTOMER HAD A TEST PERFORMED ON A LAB SYSTEM AND THE READING WAS 13%. THE DIFFERENCE BETWEEN THE TESTS COULD BE CLINICALLY SIGNIFICANT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER IS EXPECTED TO RETURN THE KIT FOR EVALUATION.