COBAS E411 DISK SYSTEM
Received Sep 25, 2013 · Event occurred Sep 4, 2013
Report 1823260-2013-05904 · MDR key 3367568
Device
Generic name
Immunochemistry Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04775279001
Lot number
NA
Product problems
- Low Test Results
Patient
039 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE ANTIBODY TO (B)(6) RESULT FOR ONE PATIENT ON THEIR E411 ANALYZER. THE PATIENT'S INITIAL (B)(6) RESULT WAS (B)(6). THIS RESULT WAS REPORTED TO THE PATIENT. THE PATIENT REQUESTED A PORTION OF THE REMAINING SAMPLE TO HAVE IT TESTED IN ANOTHER LABORATORY. THE SAMPLE WAS TESTED ON A VIDAS BIOMERIEUX ANALYZER AND THE RESULT WAS (B)(6). ON (B)(6) 2013, THE SAMPLE WAS REPEATED ON THE ORIGINAL E411 ANALYZER. THE (B)(6) RESULT WAS NOW (B)(6) WHICH WAS A (B)(6) RESULT. ACCORDING TO THE CUSTOMER, THIS RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE (B)(4) REAGENT LOT NUMBER WAS 17281901. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.
Additional Manufacturer Narrative
A PATIENT SAMPLE WAS RETURNED FOR INVESTIGATION. THE SAMPLE WAS TESTED ON AN E411, AN ORTHO SAVE ELISA, AND AN INNOGENETICS INNO-LIA HCV SCORE. THE RESULTS FROM ALL THREE WERE POSITIVE. THE SAMPLE WAS DETERMINED TO BE A TRUE POSITIVE.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).