inforMED
MalfunctionLCP

A1CNOW+

Received Feb 23, 2024 · Event occurred Feb 13, 2024

Report MW5151893 · MDR key 18777142

Device

Generic name

Assay, Glycosylated Hemoglobin

Model number

A1CNOW+

Catalog number

91192

Lot number

2224524

Patient

Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THIS IS A HOME A1C TEST KIT UNDER BRAND A1CNOW+. ONE BOX OF TEST KITS CONSISTENTLY DELIVERS A RESULT THAT IS 7 OR HIGHER. ONE BOX OF TEST KITS CONSISTENTLY DELIVERS A RESULT THAT IS 6 OR HIGHER. I DID A SIDE-BY-SIDE WHICH WAS BLOOD DRAWN SAME FINGER PIN PRICK AND THE A1C FOR ONE IS 7.4 AND THE OTHER IS 6.1. WHAT IS MORE ASTONISHING. IS THAT THIS ISN'T JUST ONE KIT MULTIPLE TESTS FROM THE SAME BOXES YIELD SIMILAR RESULTS. THE WHOLE BOX IS OFF. NOT JUST ONE TEST. THIS POINTS TO A BIGGER ISSUE. A QUICK GOOGLE SEARCH SAYS IT IS 97.8% ACCURATE TO DOCTOR TESTS. IMPOSSIBLE. REFERENCE REPORT: #MW5151894.