FLX MONO RB A HU PMS2, CL EP51, RTU,LINK

Additional Manufacturer Narrative

CORRECTION TO MANUFACTURER REGISTRATION NUMBER, CORRECT NUMBER IS (B)(4).

Description of Event or Problem

CANADA CUSTOMER REPORTED "SUSPICIOUS RESULTS" WHEN STAINING WITH PMS2. ISSUE WAS ATTRIBUTED TO BOTH USER ERROR AND OFF-LABEL USE. INCORRECT STAINING WAS DUE TO THE CUSTOMER USING THE ANTIBODY CONTAINER THEY HAD MISLABELED. THE CUSTOMER MISTAKENLY POURED THE REAGENT MSH2 INTO A USER FILLABLE BOTTLE THE CUSTOMER HAD LABELED AS PMS2. THE CUSTOMER THEN RAN THE STAINING AS PMS2 WITH THE INCORRECT MSH2 REAGENT. ADDITIONALLY, BOTH REAGENTS ARE INTENDED FOR THE AUTOSTAINER WHILE THE CUSTOMER USED THEM OFF-LABEL ON THE OMNIS SYSTEM. THE LAB CONTACTED THE CLINICIANS TO ENSURE THAT THEY ARE AWARE AND TO DETERMINE IF THERE IS ANY IMPACT ON PATIENT MANAGEMENT AND THE CUSTOMER STATES THAT THERE WERE 5 CASES FOR WHICH CORRECTED REPORTS WERE ISSUED DUE TO DIFFERENCES IN STAINING OUTCOMES BETWEEN THE INITIAL INCORRECT STAINING USING THE ANTIBODY CONTAINER MISLABELED BY THE CUSTOMER AND THE REPEAT STAINING WITH THE PROPER ANTIBODY. OF THE 5 CASES REQUIRING CORRECTED REPORTS: 1 WAS IN A PATIENT ALREADY KNOWN TO HAVE A POLYPOSIS SYNDROME - NO CLINICAL EFFECT. 3 CASES HAD REFLEX MOLECULAR TESTING THAT IDENTIFIED MOLECULAR ABNORMALITIES TO GUIDE SUBSEQUENT THERAPY - NO NEGATIVE CLINICAL IMPACT, PLUS THE TIME FRAME FROM INITIAL REPORTING TO DISCOVERY OF THE ERROR AND REPEAT STAINING WAS SHORT ENOUGH SUCH THAT THERE WERE NO IMPACTS UPON MANAGEMENT. 1 CASE WAS FOUND TO HAVE ISOLATED PMS2 LOSS ON REPEAT STAINING WHICH IS SUGGESTIVE OF POSSIBLE LYNCH SYNDROME - BUT THE CLINICAL SUSPICION WAS THERE ALREADY AS THE PATIENT WAS RELATIVELY YOUNG, AND THE LESION WAS IN THE TYPICAL RIGHT-SIDE LOCATION - LIKELY BEING REFERRED FOR GENETIC COUNSELING. CUSTOMER CONFIRMS THAT THERE WAS NO NEGATIVE CLINICAL IMPACT ON PATIENT MANAGEMENT.

Additional Manufacturer Narrative

A1-A6: PATIENT INFORMATION HAS NOT BEEN PROVIDED. THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AS BOTH REAGENTS ARE WITHIN SPECIFICATION WITH NO MALFUNCTION INDICATED, THIS REPORT WILL REMAIN AGAINST THE PMS2 PRODUCT TO ALIGN WITH THE INITIAL REPORT.

Additional Manufacturer Narrative

A1-A6: PATIENT INFORMATION HAS NOT BEEN PROVIDED. D4: LOT# WAS NOT PROVIDED. THE INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS CURRENTLY ONGOING. NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE. THEREFORE, THIS REPORT IS BEING FILED AS PART OF AGILENT'S COMMITMENT TO DUE DILIGENCE REPORTING.

Description of Event or Problem

CANADA CUSTOMER REPORTED "SUSPICIOUS RESULTS" WHEN STAINED WITH PMS2. THE CUSTOMER POURED MSH2 INTO A USER FILLABLE BOTTLE, WHICH IS AN OFF-LABEL USE, AND MISTAKENLY REGISTERED IT AS PMS2 ON OMNIS SYSTEM. IT IS BELIEVED THAT THERE ARE 4 OR 5 CASES THAT WILL REQUIRE A CORRECTED REPORT DUE TO DIFFERENCES IN STAINING DUE TO USAGE OF MIS-REGISTERED VIAL. THE LAB IS GOING TO CONTACT THE CLINICIANS TO ENSURE THAT THEY ARE AWARE AND TO DETERMINE IF THERE IS ANY IMPACT ON PATIENT MANAGEMENT. INVESTIGATION IS CURRENTLY ONGOING. NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.