ASLOT TINA-QUANT ANTISTREPTOLYSIN O

Additional Manufacturer Narrative

(B)(6). (B)(4).

Description of Event or Problem

THE CUSTOMER STATED THAT THEY HAVE BEEN GETTING ERRONEOUSLY HIGH RESULTS FOR 5 SAMPLES FROM THE SAME PATIENT TESTED WITH MULTIPLE LOT NUMBERS OF ASLOT TINA-QUANT ANTISTREPTOLYSIN O (ASLO) ON A COBAS 8000 C 702 MODULE (C702). THE RESULTS FROM THE PATIENT HAVE BEEN PERSISTENTLY HIGH AND THIS DOES NOT FIT THE CLINICAL PICTURE OF THE PATIENT. THE FIRST SAMPLE, TESTED ON (B)(6) 2016, RESULTED AS 785 KU/L. THE SECOND SAMPLE, TESTED ON (B)(6) 2016, RESULTED AS 2289.7 KU/L. THE THIRD SAMPLE, TESTED ON (B)(6) 2017, RESULTED AS 2504.0 KU/L. THE FOURTH SAMPLE, TESTED ON (B)(6) 2017, RESULTED AS 2708.4 KU/L. THE FIFTH SAMPLE, TESTED ON (B)(6) 2017, RESULTED AS 2414.5 KU/L. THIS SAMPLE WAS DILUTED TIMES FIVE AND RESULTED AS 508.5 X5 = 2542.5 KU/L. THIS SAMPLE WAS DILUTED TIMES TEN AND RESULTED AS 261.0 X 10 = 2610 KU/L. THIS SAMPLE WAS ALSO DILUTED TIMES TWENTY AND RESULTED AS 100.1 X 20 = 2002 KU/L. THE CUSTOMER STATES THAT THE ASLO TITER CONTINUES TO RISE, BUT THEY DO NOT THINK THE PATIENT HAS AN IMMUNE-MEDIATED POST-STREPTOCOCCAL COMPLICATION. THE CUSTOMER STATES THAT IF THE PATIENT DID INDEED HAVE A STREPTOCOCCAL INFECTION AT THE ONSET, THEN THE TITERS SHOULD BE SETTLING. THE CUSTOMER SUSPECTS THERE IS AN INTERFERENT IN THE PATIENT SAMPLES WHICH INTERFERES WITH THE ASLO ASSAY. THERE WERE NO ALLEGATIONS OF AN ADVERSE EVENT WITH THE PATIENT. THE SERIAL NUMBER OF THE USED C702 ANALYZER WAS REQUESTED, BUT NOT PROVIDED. SAMPLE TESTS WERE PERFORMED USING ASLO REAGENT LOT NUMBERS 144217, 196228, AND 131178.

Additional Manufacturer Narrative

THE PRESENCE OF AN INTERFERENT IN THE PATIENT SAMPLE CAN BE EXCLUDED BASED ON THE DILUTION EXPERIMENTS. THE RESULTS OF THE DILUTED SAMPLE CONFIRMED THE RESULT OF THE UNDILUTED SAMPLE. NO PRODUCT PROBLEM WAS FOUND.

Additional Manufacturer Narrative

THE CUSTOMER WAS HAVING ISSUES WITH THE ANALYZER VACUUM PUMP, SO THIS WAS EXCHANGED. PRECISION STUDIES WERE PERFORMED BEFORE AND AFTER THE PUMP EXCHANGE. THE CUSTOMER ALSO NOTED THAT THEY HAVE HAD POOR PERFORMANCE FOR PROFICIENCY SAMPLES TESTED FOR (B)(4).

Additional Manufacturer Narrative

MEDWATCH HAS BEEN UPDATED.

Additional Manufacturer Narrative

THE CUSTOMER PERFORMED AN ADDITIONAL DILUTION STUDY WITH A SIXTH SAMPLE FROM THE SAME PATIENT ON (B)(6) 2017. ALL DILUTIONS WERE PERFORMED USING SALINE AS THE DILUENT. THE FOLLOWING ALSO VALUES WERE OBTAINED FOR THE SAMPLE: 2519.9 KU/L WHEN RUN WITHOUT DILUTION. (B)(6).