LIPID + EGLU TEST STRIPS
Received Oct 31, 2024 · Event occurred Oct 1, 2024
Report 1836135-2024-00039 · MDR key 20582421
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER WAS PROVIDED EDUCATION AND TRAINING. THE CUSTOMER PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. UPON FOLLOW-UP COMMUNICATION, THE CUSTOMER INDICATED THEY IMPLEMENTED THE TRAINING, ARE GOOD, AND WILL NOT BE RETURNING THE PRODUCT. QC RETENTION WAS TESTED AND MEASURED WITHIN SPECIFICATION.
Description of Event or Problem
THE CUSTOMER REPORTED PERFORMING TWO TESTS BACK-TO-BACK ON TWO CARDIOCHEK PLUS ANALYZERS AND RECEIVED DIFFERENT RESULTS. THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE RESULTS REPORTED BY THE CUSTOMER FROM THE TWO GLUCOSE TESTS. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.