A1CNOW SELF CHECK
Received Jan 19, 2022 · Event occurred Nov 29, 2021
Report 1836135-2022-00008 · MDR key 13296944
Device
Generic name
Clinical Chemistry Analyzer
Manufacturer
Pts DiagnosticsModel number
3070Catalog number
3070
Lot number
2107749
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 HAVING TROUBLE USING THEIR A1C KIT. DURING TROUBLESHOOTING THE CUSTOMER STATED THEY HAVE ONE ANALYZER BUT TWO CARTRIDGES WITH DIFFERENT CODES. ONE MATCHES THE ANALYZER, THE OTHER DOES NOT. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS. THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE CUSTOMERS REPORT OF HAVING MISMATCHED CARTRIDGES.
Additional Manufacturer Narrative
THE CUSTOMER DID NOT RECEIVE A RESULT OR MAKE A MEDICAL DECISION BASED ON ANY TESTING USING THESE COMPONENTS. THIS REPORT IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. PTS PACKAGED LOT WITH W0 LOT CODE, PERFORMED LINE CLEARANCE AND THEN PACKAGED LOT WITH X0 CODE FOLLOWED BY ANOTHER LINE CLEARANCE BEFORE PACKAGING LOT WITH CODE Y0. THE MATERIALS FROM LOTS WITH CODES W0 AND Y0 SHOULD NOT HAVE BEEN INTERMINGLED BASED ON MANUFACTURING PROCESSES. NO OTHER COMPLAINTS HAVE BEEN ALLEGED AGAINST MIXING OF THESE LOT CODES. TO FURTHER EXAMINE THE CUSTOMER'S ALLEGATION, WE EXAMINED THE CODES PRINTED ON RETAINED TEST CARTRIDGES (6 EACH) AND ANALYZERS (3 EACH). ALL CARTRIDGES AND ANALYZERS USED ACROSS TESTING POSSESSED THE CODE W0 AS EXPECTED.