A1C TEST KIT
Received Jan 7, 2022 · Event occurred Dec 2, 2021
Report 1836135-2021-00038 · MDR key 13191364
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED SOME CONCERN OF A1C ACCURACY WHEN COMPARED TO LAB RESULTS ON THE SAME DAY OF TESTING. THE CUSTOMER COULD NOT PROVIDE SPECIFIC PATIENT RESULTS BUT GAVE GENERALIZED VALUES (I.E. A1C ~8% AND LAB ~13%, A1C ~7% AND LAB ~11%). THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THIS INCIDENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.
Additional Manufacturer Narrative
THIS REPORT IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. THE ALLEGATION COULD NOT BE FURTHER INVESTIGATED AT THIS TIME BASED ON LIMITED INFORMATION PROVIDED BY THE CUSTOMER. THE CUSTOMER HAS NOT YET RESPONDED TO MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN LOT INFORMATION AND TO PROVIDE FURTHER TROUBLESHOOTING AND INVESTIGATIVE ASSISTANCE. TRAINING MATERIALS WERE PROVIDED AND TRAINING RESOURCES WERE OFFERED TO THE CUSTOMER.