ALINITY I B12 REAGENT KIT

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P67-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P67-21/-31.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I VITAMIN B12 RESULTS FOR A 36-YEAR-OLD POSTPARTUM PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2024 AT 6:34PM: INITIAL B12 RESULT = > 1475 PMOL/L (RAW RESULT = 3361.953); RERUN USING AUTOMATIC 1:3 DILUTION = 662 PMOL/L (RAW RESULT = 897.745). ON (B)(6) 2024 AT 8:44PM RERUN MANUALLY: INITIAL B12 RESULT UNDILUTED = 204.9 PMOL/L (RAW RESULT = 277.670) AUTOMATIC 1:3 DILUTION RESULT = < 327.6 PMOL/L (RAW RESULT = 401.573) THE CUSTOMER RAN THE PATIENT¿S SERUM SAMPLE ON ANOTHER ALINITY ANALYZER AT THE CUTOMER¿S SITE ON (B)(6) 2024. THOSE RESULTS WERE AS FOLLOWS: INITIAL RESULT UNDILUTED = > 1475.6 PMOL/L (RAW RESULT = 2880.009) AUTOMATIC 1:3 DILUTION RESULT = 840.85 PMOL/L (RAW RESULT = 1139.597). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I B12 ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 65284UD00. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT 65284UD00 AND THE COMPLAINT ISSUE. CUSTOMER FIELD DATA WAS USED TO ASSESS THE PERFORMANCE OF THE ALINITY I B12 ASSAY USING WORLDWIDE DATA. REVIEW SHOWS THAT THE MEDIAN PATIENT RESULT FOR LOT 65284UD00 IS WITHIN ESTABLISHED LIMITS AND COMPARABLE WITH OTHER LOTS IN THE FIELD, CONFIRMING NO SYSTEMIC ISSUE FOR THE LOT. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I B12 REAGENT LOT 65284UD00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I VITAMIN B12 RESULTS FOR A 36-YEAR-OLD POSTPARTUM PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2024 AT 6:34PM: INITIAL B12 RESULT = > 1475 PMOL/L (RAW RESULT = 3361.953); RERUN USING AUTOMATIC 1:3 DILUTION = 662 PMOL/L (RAW RESULT = 897.745). ON (B)(6) 2024 AT 8:44PM RERUN MANUALLY: INITIAL B12 RESULT UNDILUTED = 204.9 PMOL/L (RAW RESULT = 277.670) AUTOMATIC 1:3 DILUTION RESULT = < 327.6 PMOL/L (RAW RESULT = 401.573) THE CUSTOMER RAN THE PATIENT¿S SERUM SAMPLE ON ANOTHER ALINITY ANALYZER AT THE CUTOMER¿S SITE ON (B)(6) 2024. THOSE RESULTS WERE AS FOLLOWS: INITIAL RESULT UNDILUTED = > 1475.6 PMOL/L (RAW RESULT = 2880.009) AUTOMATIC 1:3 DILUTION RESULT = 840.85 PMOL/L (RAW RESULT = 1139.597) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P67-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P67-21/-31. ADDITIONAL INFORMATION ADDED TO SECTION D10 - CONCOMITANT PRODUCT: ALNTY I PROCESSING MODU, 03R65-01, (B)(6).

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I VITAMIN B12 RESULTS FOR A 36-YEAR-OLD POSTPARTUM PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2024 AT 6:34PM: INITIAL B12 RESULT = > 1475 PMOL/L (RAW RESULT = 3361.953); RERUN USING AUTOMATIC 1:3 DILUTION = 662 PMOL/L (RAW RESULT = 897.745). ON 23NOV2024 AT 8:44PM RERUN MANUALLY: INITIAL B12 RESULT UNDILUTED = 204.9 PMOL/L (RAW RESULT = 277.670) AUTOMATIC 1:3 DILUTION RESULT = < 327.6 PMOL/L (RAW RESULT = 401.573). THE CUSTOMER RAN THE PATIENT¿S SERUM SAMPLE ON ANOTHER ALINITY ANALYZER AT THE CUSTOMER¿S SITE ON 23NOV2024. THOSE RESULTS WERE AS FOLLOWS: INITIAL RESULT UNDILUTED = > 1475.6 PMOL/L (RAW RESULT = 2880.009) AUTOMATIC 1:3 DILUTION RESULT = 840.85 PMOL/L (RAW RESULT = 1139.597). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.