THE CUSTOMER REPORTED REPEATABLE FALSE POSITIVE LUTENIZING HORMONE (HLH) RESULTS FOR SEVEN (7) PATIENTS WITH PRECOCIOUS PUBERTY SIGNS, GENERATED FROM THEIR LABORATORY'S TWO UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEMS, DURING (B)(6) 2013 TO (B)(6) 2014. SERIAL NUMBERS FOR THE INSTRUMENTS ARE (B)(4). THE SAMPLE FROM PATIENT 7 WAS TESTED ON THE DXI 800 INSTRUMENT WITH SERIAL NUMBER (B)(4). IT IS UNKNOWN WHICH OF THE TWO DXI 800 INSTRUMENTS SOME OF THE RESULTS WERE GENERATED FROM. THE CUSTOMER REPORTED THAT HIGH HLH RESULTS DID NOT DECREASE AS EXPECTED, AFTER THE PATIENTS WERE PROVIDED TREATMENT WITH A LH/RH ANALOG. THE LABORATORY EXPECTED HLH RESULTS TO BE WELL UNDER 1 MIU/ML AFTER TREATMENT. BECAUSE THE HLH VALUES GENERATED BY THE DXI 800 ANALYZERS DID NOT DECREASE AFTER TREATMENT, THE CUSTOMER ALLEGED THAT SOME PATIENTS RECEIVED UNNECESSARY INJECTIONS OF LH/RH ANALOG. THE CUSTOMER ALSO STATED THAT THE DXI ANALYZERS SOMETIMES GENERATED HIGH HLH RESULTS FOR YOUNG PATIENTS WITHOUT SIGNS OF PUBERTY. RE-ANALYSIS OF SOME OF THESE SAMPLES ON AN ALTERNATIVE METHOD GENERATED EXPECTED LOW HLH RESULTS (
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Patient 1
(B)(6). THE CUSTOMER PROVIDED ARCHIVE DATA FILES FOR BOTH DXI INSTRUMENTS AND ANALYSIS OF THE FILES DID NOT REVEAL AN ISSUE WITH THE INSTRUMENT AND/OR ASSAY PERFORMANCES. THE CUSTOMER PROVIDED QUALITY CONTROL (QC) RESULTS FOR BOTH ANALYZERS WHICH INDICATE THAT QC IS RECOVERING WITHIN THE CUSTOMER'S ESTABLISHED RANGES. CALIBRATION CURVES FOR THE HLH ASSAY RUN ON BOTH ANALYZERS ALSO PASSED WITH GOOD SPECIFICATIONS THAT ARE WITHIN THE ASSAY'S GUIDELINE. ANALYSIS OF EVENT LOGS FROM BOTH INSTRUMENTS ALSO DID NOT HIGHLIGHT ANY SPECIFIC ISSUE EXCEPT A HIGH OCCURRENCE OF SAMPLE HANDLING RELATED ERRORS, NAMELY "INSUFFICIENT SAMPLE IN SAMPLE TUBE" AND "ASPIRATION MONITOR DETECTED POSSIBLE OBSTRUCTION" ERRORS. THE CUSTOMER PROVIDED BECKMAN COULTER WITH TWO (2) PATIENT SAMPLES FOR INVESTIGATION. BECKMAN COULTER TESTED THE PATIENT SAMPLES NEAT (UNDILUTED AND UNALTERED) FOLLOWING CENTRIFUGATION FOR THE HLH ASSAY AND OBTAINED HIGH HLH RESULTS WHICH CONFIRMED THE CUSTOMER'S RESULTS. BECKMAN COULTER THEN PERFORMED AN INTERFERENCE TESTING USING A MIX OF DIFFERENT BLOCKERS WHICH DEMONSTRATED THE PRESENCE OF AN INTERFERENCE SUBSTANCE RELATED TO ALKALINE-PHOSPHATASE, CAUSING GENERATION OF FALSELY ELEVATED HLH RESULTS. IN CONCLUSION, THE CAUSE OF THE FALSELY ELEVATED HLH RESULTS MAY BE ATTRIBUTED TO THE PRESENCE OF AN INTERFERING SUBSTANCE RELATED TO ALKALINE-PHOSPHATASE. THIS REPORT IS ONE OF SEVENTEEN REPORTS ASSOCIATED WITH THIS EVENT. THE FOLLOWING IS A LIST OF ALL REPORTS ASSOCIATED WITH THIS EVENT: 2122870-2014-00673, 2122870-2014-00674, 2122870-2014-00675, 2122870-2014-00681, 2122870-2014-00682, 2122870-2014-00683, 2122870-2014-00684, 2122870-2014-00685, 2122870-2014-00686, 2122870-2014-00687, 2122870-2014-00688, 2122870-2014-00689, 2122870-2014-00690, 2122870-2014-00691, 2122870-2014-00692, 2122870-2014-00693, 2122870-2014-00694.