inforMED
MalfunctionCGA

NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS

Received Dec 9, 2025 · Event occurred Sep 27, 2025

Report 23756997 · MDR key 23756997

Device

Generic name

Glucose Oxidase, Glucose

Lot number

0425199303

Product problems

  • Defective Device

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

DAYSHIFT STAFF HAD ISSUES WITH NONE OF THE GLUCOMETERS PASSING THE LEVEL 3 (RED) QC'S [QUALITY CONTROLS]. THEY THOUGHT IT WAS AN ISSUE WITH THE GLUCOMETERS BECAUSE THEY TRIED MULTIPLE BOTTLES OF THE LEVEL 3 FLUID. HOWEVER, WHEN I TRIED IT, I NOTICED ALL THE BOTTLES WERE FROM THE SAME LOT NUMBER (0425199303, EXPIRES 01-18-2028). I FOUND A BOTTLE FROM A DIFFERENT LOT AND THEY ALL PASSED. I HAVE DISPOSED OF ALL THE BOTTLES ON OUR UNIT WITH THIS SAME LOT NUMBER.