COBAS 6000 E601 MODULE

Additional Manufacturer Narrative

INVESTIGATION OF THE PATIENT SAMPLE VERIFIED THE POSITIVE ELECSYS TOXOPLASMA IGG RESULTS. THE POSITIVE RESULTS WAS FURTHER CONFIRMED BY NEUTRALIZATION ASSAY AS WELL AS COMPETITOR ASSAYS, BOUTY BEIA TOXOPLASMA IGG ASSAYS (QUANT AND AVIDITY). THE ELCSYS TOXOPLASMA IGG RESULTS ARE REGARDED AS CORRECTLY REACTIVE. NO ADVERSE EVENTS WERE REPORTED.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE CUSTOMER RECEIVED QUESTIONABLE TOXOPLASMA IGG (IGG ANTIBODIES TO TOXOPLASMA GONDII) FOR ONE PATIENT SAMPLE. THE INITIAL TOXOPLASMA IGG RESULT WAS 121.4 IU/ML. THE PHYSICIAN ORDERED ADDITIONAL TESTING BE PERFORMED. THE SAMPLE WAS REPEATED USING AN UNKNOWN COMPETITOR ASSAY, IT GENERATED A NEGATIVE RESULT. AVIDITY TESTING PERFORMED ON THE SAMPLE WAS ALSO NEGATIVE. THE PATIENT'S TOXOPLASMA IGM RESULTS HAVE ALWAYS BEEN NEGATIVE. ALL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND TO THE PHYSICIAN. THE PATIENT WAS NOT HARMED BY THE EVENT. THE TOXOPLASMA IGG REAGENT LOT NUMBER WAS 00158276.