COBAS 6000 E601 MODULE
Received Oct 4, 2011 · Event occurred Sep 6, 2011
Report 1823260-2011-05212 · MDR key 2274644
Device
Generic name
Immunochemistry Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04745922001
Lot number
NA
Product problems
- High Test Results
Patient
030 YR
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE PATIENT SAMPLE WAS RETURNED FOR INVESTIGATION. REACTIVE/POSITIVE RESULTS WERE OBTAINED. THE POSITIVE TOTO IGG RESULT IS REGARDED AS CORRECTLY POSITIVE. THE PATIENT WAS NOT HARMED.
Additional Manufacturer Narrative
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THE EVENT OCCURRED IN (B)(6).
Additional Manufacturer Narrative
THE PATIENT HAD NEGATIVE TOXO IGG RESULTS ON A VIDAS ANALYZER FOR THE PREVIOUS EIGHT MONTHS.
Description of Event or Problem
THE CUSTOMER RECEIVED QUESTIONABLE IGG ANTIBODIES TO TOXOPLASMA GONDII (TOXO IGG) RESULTS ON THEIR E601 ANALYZER. THE PATIENT WAS BEING MONITORED MONTHLY DURING HER PREGNANCY FOR TOXO IGG USING A VIDAS ANALYZER WITH NEGATIVE RESULTS, <8 IU/ML. PRIOR TO DELIVERY, THE PATIENT'S TOXO IGG RESULTS WERE 88 IU/ML AND 86 IU/ML ON THE E601 ANALYZER. THE PATIENT'S SAMPLE WAS SENT TO ANOTHER LABORATORY FOR REPEAT TESTING AS THE PATIENT HAD BEEN TESTING NEGATIVE FOR TOXO IGG. THE SAMPLE WAS REPORTED AS NEGATIVE USING A VIDAS ANALYZER. THE CUSTOMER CONSIDERS THE RESULTS FROM THE E601 TO BE FALSE POSITIVE RESULTS. THERE WERE NO ALLEGATIONS OF ADVERSE AFFECTS TO THE PATIENT AS A RESULT OF THIS EVENT. THE TOXO IGG REAGENT LOT NUMBER WAS 161442 AND THE EXPIRATION DATE WAS 12/30/2011. NO ROOT CAUSE HAS BEEN DETERMINED. THE INVESTIGATION IS ONGOING.