TOSOH ST AIA-PACK CA 19-9
Received Jan 13, 2015 · Event occurred Dec 19, 2014
Report 3005529799-2015-00001 · MDR key 4425262
Device
Generic name
Aia Ca 19-9
Manufacturer
Tosoh Aia, Inc.Model number
NACatalog number
025271
Lot number
E511510
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
(B)(6) 2014: TOSOH BIOSCIENCE WAS NOTIFIED THAT AN INCORRECT CA 19-9 RESULT HAD BEEN RELEASED THE PREVIOUS WEEK WHEN A NEW PATIENT DIAGNOSED WITH PANCREATIC CANCER WAS TESTED FOR CA 19-9. THE SPECIMEN WAS RUN STRAIGHT (NO DILUTION WAS DONE) AND THE CA 19-9 RESULT WAS REPORTED AS 258 U/ML. THE PATIENT RETURNED THE FOLLOWING WEEK FOR RETESTING. THE SAMPLE WAS ICTERIC (BILIRUBIN = 9.6 MG/DL) SO IT WAS DECIDED TO RUN THE SPECIMEN FOR CA 19-9 STRAIGHT AND DILUTED. CA 19-9 RESULTS: STRAIGHT = 252 U/ML, 1:2 DILUTION > 400 U/ML, SERIAL DILUTION, 1:1000 APPROXIMATELY 400,000 U/ML. ALL QCS WERE IN RANGE ON BOTH DAYS FOR ALL ASSAYS, NO OTHER ASSAY ISSUES. ROOT CAUSE: HIGH DOSE HOOK EFFECT FOR CA 19-9 MAY OCCUR ON SPECIMENS > 200,000 U/ML.