ALINITY I B12 REAGENT KIT

Additional Manufacturer Narrative

COMPLETED INFORMATION FOR SECTION A1 PATIENT IDENTIFIER: SID (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P67-32 HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P67-21/-31.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I B12 RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: ON B)(6) 2024 SID (B)(6) INITIAL RESULT = 400 PMOL/L, REPEATS = 288 PMOL/L, 188 PMOL/L, 211 PMOL/L, 247 PMOL/L, AND 278 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

SECTION D4 PRIMARY UDI NUMBER WAS UPDATED FROM (B)(4) TO (B)(4). 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. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 56198UD00 AND THE COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ALINITY I B12 WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. REVIEW SHOWS THAT THE MEDIAN PATIENT RESULTS FOR LOT 56198UD00 IS COMPARABLE WITH OTHER LOTS IN THE FIELD CONFIRMING NO SYSTEMIC ISSUE FOR THE LOT. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I B12 REAGENT FOR LOT 56198UD00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I B12 RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: 11JAN2024 SID (B)(6) INITIAL RESULT = 400 PMOL/L, REPEATS = 288 PMOL/L, 188 PMOL/L, 211 PMOL/L, 247 PMOL/L, AND 278 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.