COBAS 6000 E601 MODULE
Received Aug 8, 2011 · Event occurred Jul 10, 2011
Report 1823260-2011-04278 · MDR key 2195680
Device
Generic name
Immunochemistry Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04745922001
Lot number
2119-04
Product problems
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
IT IS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).
Additional Manufacturer Narrative
NEW INFORMATION WAS ADDED.
Additional Manufacturer Narrative
THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. ONE SAMPLE WAS PROVIDED FOR INVESTIGATION AND THE POSITIVE TOXOPLASMA IGG RESULT OBTAINED BY THE CUSTOMER COULD NOT BE VERIFIED. THIS SAMPLE TESTED NEGATIVE FOR TOXOPLASMA IGG AS WELL AS TOXOPLASMA IGM AND WAS CONSISTENT WITH THE RESULTS OBTAINED FROM THE COMPETITOR ASSAY. THE CUSTOMER CONFIRMED THE INVESTIGATION RESULTS AND NO FURTHER INVESTIGATION WAS DONE. NO ADVERSE EVENTS WERE REPORTED.
Description of Event or Problem
THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE. THE DISCREPANT RESULTS LED TO AN UNCLEAR TOXOPLASMA IGG STATUS FOR THE PATIENT. THE TOXOPLASMA IGG REAGENT (IGG ANTIBODIES TO TOXOPLASMA GONDII) LOT NUMBER WAS 161442. THE ROCHE ELECSYS RESULT WAS 301.50 IU/ML. THE CONFIRMATORY TEST RESULT (USING A LIASON INSTRUMENT) WAS <3.0 IU/ML. IT IS UNKNOWN WHICH RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVNETS HAVE BEEN ALLEGED REGARDING THE DISCREPANCIES.