Description of Event or Problem · 1
TWO COMPLAINTS WERE RECEIVED IN SEPTEMBER 2006, THAT CUSTOMERS HAD BEEN SEEING A HIGH BIAS ON PATIENT SAMPLES WHEN ASSAYED FOR AMMONIA USING THE BAYER ADVIA 2400 SYSTEM. BOTH OF THESE COMPLAINTS INVOLVED A SINGLE LOT OF THE AMMONIA ASSAY, LOT 077500 AND IN BOTH CASES, THE CONTROL VALUES WERE WITHIN ACCEPTABLE RANGES. IN AN EFFORT TO EVALUATE THE ROOT CAUSE, MATERIAL FROM THIS LOT WAS TESTED IN-HOUSE AND SHOWED SIMILAR RESULTS. BAYER SUPPORT ESCALATED THIS COMPLAINT WITHIN BAYER'S COMPLAINT HANDLING PROCESS ON OCTOBER 3, 2006. THIS MDR IS BEING SUBMITTED BECAUSE A REMOTE POSSIBILITY EXISTS OF A SERIOUS ADVERSE EVENT WHERE A FALSELY ELEVATED AMMONIA RESULT COULD LEAD TO AN ERRONEOUS DIAGNOSIS OF HEPATIC ENCEPHALOPATHY, AND THUS MASK A DISTINCT TREATABLE CAUSE. THE ERRONEOUS TEST RESULT COULD CONTRIBUTE TO AN ADVERSE EVENT SHOULD THE PATIENT BE TREATED BASED UPON THE SINGLE TEST RESULT WITHOUT FURTHER DIAGNOSTIC OR MEDICAL EVALUATION. IN THE INTERIM, CUSTOMERS ARE BEING INFORMED TO DISCONTINUE USE OF THIS SPECIFIC LOT. WE CONTINUE TO EVALUATE THE ROOT CAUSE FOR THIS COMPLAINT, AND MONITOR FIELD REPORTS FOR THE AMMONIA ASSAY. THERE WERE NO REPORTED ADVERSE EVENTS IN THE TWO COMPLAINTS THAT WERE RECEIVED.