MalfunctionLCP
A1C TEST KIT
Received Oct 14, 2021 · Event occurred Sep 7, 2021
Report 1836135-2021-00033 · MDR key 12636622
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS REPORT IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. AT THE TIME OF COMMUNICATION, THE CUSTOMER NO LONGER HAD THE PRODUCT AND COULD NOT OBTAIN LOT INFORMATION. CUSTOMER NOTED HAVING DIFFICULTY WITH TEST KITS IN THE PAST.
Description of Event or Problem
THE CUSTOMER REPORTED ACCURACY CONCERNS WHEN USING THEIR A1C KIT. THE CUSTOMER REPORTED RECEIVING A 7.3% ON THE KIT AND 12% FROM A LAB. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THE INCIDENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.