COBAS INTEGRA PHOSPHORUS 2

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

THE USER RECEIVED A QUESTIONABLE PHOSPHORUS RESULT FOR ONE PATIENT SAMPLE FROM THE INTEGRA 800 SERIAL NUMBER (B)(4). THE ISSUE WAS DISCOVERED WHEN SAMPLES TESTED (B)(6) 2011 THROUGH (B)(6) 2011 WERE REPEATED DUE TO A PHYSICIAN QUESTIONING A PATIENT RESULT. THE INITIAL RESULT WAS 5.1 MG/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED ON (B)(6) 2011 ON ANOTHER INTEGRA 800 ANALYZER AT THE SITE AND THE RESULT WAS 6.9 MG/DL. THE PATIENT WAS NOT TREATED ON THE BASIS OF THE ORIGINAL REPORTED RESULT AND SUFFERED NO ADVERSE CONSEQUENCES FROM THIS INCIDENT. THE PHOSPHORUS REAGENT LOT IN USE AT THE TIME OF THE REPEAT TESTING WAS 63820201. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A BREAK IN THE LIQUID LEVEL SENSE CABLE AND REPLACED IT. HE ALSO REPLACED BROKEN PROBE HOLDERS AS A PRECAUTION. TO VERIFY THE ANALYZER OPERATION, HE RAN PERFORMANCE TESTING.