COBAS 6000 E601 MODULE
Received May 2, 2013 · Event occurred Apr 22, 2013
Report 1823260-2013-02706 · MDR key 3090356
Device
Generic name
Immunochemistry Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04745922001
Lot number
NA
Product problems
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE PATIENT SAMPLES WERE INVESTIGATED AND WERE FOUND TO BE NEGATIVE ON TWO DIFFERENT IMMUNOASSAY MANUFACTURERS' METHODS. NO ADDITIONAL SAMPLE WAS AVAILABLE FOR FURTHER INVESTIGATION.
Description of Event or Problem
THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE ANTIBODY TO (B)(6) RESULTS ON THEIR E601 ANALYZER. THE CUSTOMER PROVIDED DATA FOR TWO PATIENTS, ONE OF WHICH HAD DISCREPANT RESULTS. THE SPECIFIC DATE OF THIS EVENT WAS NOT KNOWN. THE PATIENT'S INITIAL (B)(6) RESULT WAS (B)(6) AND IT WAS INTERPRETED AS (B)(6). THE SAMPLE WAS REPEATED USING THE LUMIPULSE F (FUJIREBIO) METHOD. THE REPEAT RESULT WAS (B)(6) AND IT WAS INTERPRETED AS (B)(6). IT WAS UNKNOWN IF EITHER RESULT WAS REPORTED OUTSIDE THE LABORATORY. THERE WERE NO ADVERSE EVENTS. THE AHCV REAGENT LOT NUMBER AND EXPIRATION DATE WAS NOT PROVIDED.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).