D
Patient 1
THE CUSTOMER RECEIVED QUESTIONABLE AMMONIA RESULTS ON THEIR C501 ANALYZER. ALL SAMPLES TESTED WERE ALIQUOTS FROM THE PRIMARY TUBES. THE PATIENT'S INITIAL ALIQUOT'S AMMONIA RESULT WAS 304 MMOL/L ACCOMPANIED BY A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S SECOND ALIQUOT'S AMMONIA RESULT WAS 258 MMOL/L ACCOMPANIED BY A DATA FLAG. THE PATIENT'S THIRD ALIQUOT, RUN ON ANOTHER C501 (SERIAL NUMBER (B)(4)) (C2), HAD AN AMMONIA RESULT OF 101 MMOL/L ACCOMPANIED BY A DATA FLAG. THE PATIENT'S FOURTH ALIQUOT, RUN ON THE ORIGINAL C501 (C1), HAD AN AMMONIA RESULT OF 100 MMOL/L. THE CUSTOMER QUESTIONED THE AMMONIA RESULTS WHICH WERE ABOVE THE LABORATORY'S REFERENCE RANGE AND ASKED THE NURSE TO HAVE A NEW SAMPLE DRAWN. THE FIRST ALIQUOT FROM THE SECOND SAMPLE WAS RUN ON C1 AND HAD AN AMMONIA RESULT OF 107 MMOL/L ACCOMPANIED BY A DATA FLAG. THE SECOND ALIQUOT FROM THE SECOND SAMPLE WAS RUN ON C1 HAD AN AMMONIA RESULT OF 29 MMOL/L. THE THIRD ALIQUOT FROM THE SECOND SAMPLE WAS RUN ON C2 AND HAD AN AMMONIA RESULT OF 29 MMOL/L. THE FOURTH ALIQUOT FROM THE SECOND SAMPLE WAS RUN IN C2 AND HAD AN AMMONIA RESULT OF 26 MMOL/L. THE CUSTOMER BELIEVED THE SECOND SAMPLE'S RESULT OF 29 OR 26 MMOL/L TO BE CORRECT, BUT ONLY THE INITIAL RESULT OF 304 MMOL/L WAS REPORTED. THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL BASED ON THE REPORTED RESULT. THE PATIENT DID NOT HAVE TREATMENT GIVEN OR WITHHELD BASED ON THE REPORTED RESULT. THERE WERE NO ADVERSE AFFECTS FROM THIS EVENT. THE AMMONIA REAGENT LOT NUMBER WAS 64083501 AND THE EXPIRATION DATE WAS 09/30/2012. THE FIELD SERVICE REPRESENTATIVE FOUND CONTAMINATED SAMPLE LINES ON THE ANALYZER. HE CLEANED THE SAMPLE AND REAGENT LINES WITH CHLORINE DIOXIDE. HE CLEANED THE WATER CONTAINER. HE PERFORMED A CHECK TEST AND A PRECISION TEST WITH PASSING RESULTS. THE SYSTEM WAS OPERATIONAL.