A1C SELF CHECK
Received May 5, 2023 · Event occurred Apr 7, 2023
Report 1836135-2023-00016 · MDR key 16876397
Device
Generic name
A1c Testing Kit
Manufacturer
Pts DiagnosticsModel number
3055Catalog number
3055
Lot number
2229418
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS ALLEGATION WAS REPORTED OUT OF AN ABUNDANCE OF CAUTION. THE KIT APPEARS TO HAVE BEEN ACCEPTED AS A RETURN (ALTHOUGH THIS PRODUCT IS NON-RETURNABLE), THEN WAS RESEALED AND PLACED FOR SALE. THE SELLER WAS NOTIFIED OF THIS OCCURRENCE.
Description of Event or Problem
THE CUSTOMER REPORTED THAT UPON OPENING THEIR A1C SELF-CHECK KIT, THEY OBSERVED THAT TWO LANCETS HAD BEEN USED AND A BLOOD COLLECTOR THAT WAS PRESENT HAD BEEN USED ALSO. THE CUSTOMER ALSO NOTED THAT THE BOX HAD BEEN SLICED OPEN AND TAPED BACK (USED AND RE-SEALED). THE CUSTOMER DID NOT ATTEMPT TO USE ANY OF THE PRODUCT AND REPORTED NO USER WAS HURT OR INJURED. THIS ALLEGATION IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.