PTS PANELS GLUCOSE TEST STRIPS
Received Jul 30, 2024 · Event occurred Jul 1, 2024
Report 1836135-2024-00028 · MDR key 19862261
Device
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER HAS NOT YET RETURNED PRODUCT FOR INVESTIGATION; HOWEVER A RETURN HAS BEEN REQUESTED. QC RETENTION WAS TESTED AND MEASURED WITHIN SPECIFICATION (ALL WITHIN ZONE A). THIS EVENT IS BEING REPORTED TO THE FDA OUT OF AN ABUNDANCE OF CAUTION.
Description of Event or Problem
THE CUSTOMER REPORTED RECEIVING HIGH GLUCOSE RESULTS FROM THEIR CARDIOCHEK PLUS ANALYZER ON MULTIPLE PATIENTS. THE CUSTOMER REPORTED THEY WERE PERFORMING A COMPARISON VS LAB. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. MULTIPLE VALUES MEASURED WITHIN ZONE B AND ONE WITHIN ZONE C OF THE GLUCOSE CONSENSUS ERROR GRID WHEN COMPARED TO THE PROVIDED LAB VALUES.