AXSYM CEA
Received May 27, 2011 · Event occurred May 6, 2011
Report 1415939-2011-00164 · MDR key 2105805
Device
Generic name
Quantitative Measurement Of Carcinoembryonic Antigen (cea)
Manufacturer
Abbott LaboratoriesCatalog number
3K47-20
Lot number
96293M502
Product problems
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER STATED A PATIENT SPECIMEN GENERATED A NORMAL CEA RESULT OF 4.7 NG/ML ON THE AXSYM WITH A DELTA CHECK ALERT AS THE PREVIOUS SPECIMEN WAS >500 NG/ML. THE SPECIMEN WAS RETESTED WITHOUT ANY ADDITIONAL CENTRIFUGATION AND A VALUE OF >500 NG/ML WAS GENERATED. THE SPECIMEN WAS MANUALLY DILUTED YIELDING A VALUE OF 3957 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
EVALUATION - COMPLAINT REVIEW. EVALUATION - REFER TO RESULTS OF INVESTIGATION BELOW. A COMPLAINT REVIEW FOR LIST NUMBER 3K47 WAS COMPLETED FOR THE DATE RANGE OF (B)(6) 2011. NO ADVERSE TREND WAS IDENTIFIED. ADDITIONALLY, ACCURACY TESTING USING THE CEA PANEL INDICATED THAT THE PRODUCT IS PERFORMING AS EXPECTED. THIS INVESTIGATION INDICATES THAT THE PRODUCT IS EFFECTIVE AND IS PERFORMING ACCEPTABLY.
Additional Manufacturer Narrative
(B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.