A1CNOW+ PROFESSIONAL TEST KIT
Received Sep 17, 2021 · Event occurred Aug 13, 2021
Report 1836135-2021-00030 · MDR key 12490600
Device
Generic name
Clinical Chemistry Analyzer
Manufacturer
Pts DiagnosticsModel number
3021Catalog number
3021
Lot number
2028638
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
THE CUSTOMER COMPLAINT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION BASED ON THE CUSTOMER PROVIDED RESULTS. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. QC RETENTION WAS INVESTIGATED. THE QC RETENTION MEASURED WITHIN SPECIFICATIONS. THE CUSTOMER HAS NOT YET RESPONDED TO ATTEMPTS TO HAVE PRODUCT RETURNED FOR INVESTIGATION. THIS LOT OF A1CNOW PRODUCT HAS HAD NO OTHER ACCURACY-RELATED COMPLAINTS LODGED AGAINST IT.
Description of Event or Problem
THE CUSTOMER REPORTED A PATIENT WHO TESTED AT 7.6% HBA1C ON THE A1C TEST KIT AND WENT TO THE DOCTOR THREE DAYS LATER AND RECEIVED A RESULT OF 11.6% HBA1C. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.