ELECSYS CEA ASSAY
Received Jul 8, 2019 · Event occurred Jun 12, 2019
Report 1823260-2019-02448 · MDR key 8768950
Device
Generic name
Carcinoembryonic Antigen Test System
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04491777190
Lot number
355429
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6). CALIBRATION SIGNALS WERE LOWER THAN EXPECTED. THE QC DATA THAT WAS PROVIDED WAS WITHIN THE ACCEPTABLE RANGE. LIQUID FLOW CLEANING WAS PERFORMED ON SCHEDULE. DAILY MAINTENANCE WAS DONE AS SPECIFIED. THE CUSTOMER WAS NOT HAVING PROBLEMS WITH OTHER TESTS. SINCE THE RESULTS IN QUESTION OCCURRED IN SUCCESSION WHEN A NEW REAGENT PACK WAS USED, THE MALFUNCTION IS CONSISTENT WITH FOAM OR BUBBLES ON THE REAGENT SURFACE. NEITHER A GENERAL INSTRUMENT OR REAGENT ISSUE WERE IDENTIFIED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR 7 PATIENT SAMPLES TESTED FOR ELECSYS CEA ASSAY (CEA) ON A COBAS 8000 E 602 MODULE. BASED ON THE DATA PROVIDED, THE RESULTS FOR 6 PATIENT SAMPLES WERE DISCREPANT. THE LOW RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE CUSTOMER THINKS THERE MAY HAVE BEEN SOME BUBBLES ON THE REAGENT BECAUSE THE RESULTS IN QUESTION OCCURRED RIGHT WHEN THEY STARTED TO USE A NEW REAGENT PACK AND OCCURRED IN SUCCESSION. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E602 MODULE SERIAL NUMBER WAS (B)(4).