ARCHITECT CEA
Received Apr 25, 2019
Report 3008344661-2019-00053 · MDR key 8549033
Device
Generic name
Carcinoembryonic Antigen
Manufacturer
Abbott IrelandCatalog number
07K68-27
Lot number
90357FN00
Product problems
- Low Test Results
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A REVIEW OF COMPLAINT ACTIVITY DETERMINED THAT THERE WAS NORMAL COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT 90357FN00. TRACKING AND TRENDING REPORT REVIEW FOR THE ARCHITECT CEA ASSAY DETERMINED THAT THERE WERE NO TRENDS IDENTIFIED. SINCE NO PATIENT SAMPLE WAS AVAILABLE FOR TESTING, A SERUM-BASED PANEL OF SAMPLES, WHICH MIMICS A PATIENT SAMPLE, WAS PERFORMED USING A RETAINED KIT OF LOT 90357FN00; ALL SPECIFICATIONS WERE MET, AND THE LOT PERFORMED ACCEPTABLY. FIELD DATA WAS REVIEWED AND DETERMINED THE PATIENT MEDIAN RESULT FOR LOT 90357FN00 IS COMPARABLE WITH OTHER LOTS IN THE FIELD. MANUFACTURING DOCUMENTATION WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. ADDITIONALLY, LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CEA ASSAY WAS IDENTIFIED.
Additional Manufacturer Narrative
ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER REPORTED FALSE DECREASED CEA RESULTS WHEN PROCESSING ON THE ARCHITECT I2000SR FOR SID (B)(6). THE INITIAL RESULT WAS 0.5 AND RETEST WAS 22.0. PREVIOUS RESULTS WERE 15.6 AND 8.5. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.