COBAS 6000 E601 MODULE

Description of Event or Problem

THE USER RECEIVED QUESTIONABLE TOXOPLASMA IGG (IGG ANTIBODIES TO TOXOPLASMA GONDII) RESULTS FOR ONE PATIENT SAMPLE. A WOMAN WHO WAS KNOWN TO BE TOXOPLASMA IGG NEGATIVE THREE MONTHS AGO WAS RETESTED ON (B)(6) 2010. THE FIRST RESULT RECEIVED WAS 54.59 IU/ML (POSITIVE) AND THE REPEAT RESULT WAS 54.40 IU/ML (POSITIVE). TO CLARIFY THE POSITIVE RESULT, THE SAME SAMPLE WAS TESTED ON A VIDAS ANALYZER AND FOUND NEGATIVE. NO SPECIFIC DATA WAS PROVIDED FOR THIS RESULT. THE FIELD SERVICE REPRESENTATIVE NOTICED THAT THE SERUM WAS HEMOLYTIC AND RECENTRIFUGED THE SAMPLE. HE THEN MEASURED IT IN A SAMPLE CUP WITH A POSITIVE RESULT. NO SPECIFIC DATA WAS PROVIDED FOR THIS RESULT. A SECOND TUBE FROM THIS PATIENT DRAWN TWO HOURS AFTER THE FIRST SAMPLE WAS TESTED AND THE RESULT WAS NEGATIVE AT 0.130 IU/ML. NONE OF THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE ISSUE. THE TOXOPLASMA IGG REAGENT LOT NUMBER WAS 158276. THE USER STATED THEY BELIEVE THE ERRONEOUS RESULT WAS DUE TO CONTAMINATION OF THE SAMPLE.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Additional Manufacturer Narrative

THE PATIENT SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. A ROOT CAUSE COULD NOT BE IDENTIFIED. NO ADVERSE EVENTS WERE REPORTED.