COBAS 6000 E601 MODULE
Received Oct 31, 2014 · Event occurred Oct 4, 2014
Report 1823260-2014-08442 · MDR key 4216797
Device
Generic name
Immunochemistry Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04745922001
Lot number
NA
Product problems
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER RECEIVED A QUESTIONABLE CARCINOEMBRYONIC ANTIGEN (CEA) RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 5.27 NG/ML AND WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT DID NOT ACCEPT THE RESULT AS HE REGULARLY HAD THIS TEST TAKEN AND CLAIMED TO HAVE A RESULT AROUND 1 NG/ML. THE PATIENT WENT TO ANOTHER LABORATORY TO HAVE HIS BLOOD RETESTED. THE SECOND LABORATORY USED THE COBAS E411 ANALYZER AND GAVE A RESULT CLOSE TO WHAT THE PATIENT CLAIMED. NO SPECIFIC DATA WAS PROVIDED. ON (B)(6) 2014, THE CUSTOMER REPEATED TESTING ON THE ORIGINAL SAMPLE AND THE RESULT WAS 1.94 NG/ML. INFORMATION CONCERNING IF THE PATIENT WAS ADVERSELY AFFECTED WAS REQUESTED, BUT WAS NOT PROVIDED. THE CEA REAGENT LOT NUMBER WAS 174099 WITH AN EXPIRATION DATE OF 01/30/2015.
Additional Manufacturer Narrative
THE PATIENT WAS NOT ADVERSELY AFFECTED AS HE IMMEDIATELY HAD HIS BLOOD RETESTED IN ANOTHER LABORATORY.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Additional Manufacturer Narrative
A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. REVIEW OF THE PROVIDED CALIBRATION AND QC DATA DID NOT INDICATE A GENERAL REAGENT OR SYSTEM ISSUE.