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Additional Manufacturer Narrative

QC ON CNTL WAS NOT RUN ON THE SHIFT WHICH REPORTED THE RESULTS IN QUESTION, THE LAST QC RUN FOR CNTL WAS 16 HRS PRIOR ON 8/29 AT 5 PM. AT THAT TIME THE QC RESULTS FOR BR31182 WERE: LEVEL11= 0.29 X= 0.31 (0.18 TO 0.44). LEVEL13= 11.4 X= 13.8 (11.0 TO 16.6). WHEN ASKED, THE CUSTOMER INDICATED THAT THEY DID NOT UTILIZE A DELTA CHECK FOR THIS HIGH CTNL. THEY INDICATED THAT IS SOMETHING THEY SHOULD HAVE PERFORMED, BUT DID NOT. WE ALSO QUESTIONED WHY QC WAS NOT RUN MORE RECENTLY THAN FROM THE 16 HRS PRIOR, WE WERE TOLD THEY TYPICALLY RUN QC ONCE EVERY 24 HRS. WE ASKED ABOUT SAMPLE INTEGRITY AND THEY INDICATED THAT THE SAMPLE WAS CLEAR, NOT TURBID AND WITHOUT FIBRIN. WHEN ASKED WHEN THE LAST TIME THE ANALYZER HAD BEEN RUN OR WAS THERE A SHUTDOWN DONE AT SOME TIME, THEY INDICATED THAT THERE WAS NO SHUTDOWN, BUT THE ANALYZER HAD BEEN RUN ABOUT 2 HRS EARLIER TO RUN A PAS AND TSH PT SAMPLE AND THAT QC WAS JUST RUN PRIOR TO THIS FOR BOTH OF THOSE ASSAYS. THEY INDICATED THAT THE QC FOR PA AND TSH WAS IN AT THE TIME.