ACCESS VITAMIN B12

Additional Manufacturer Narrative

AN INTERNAL INVESTIGATION WAS PERFORMED. BECKMAN COULTER HAS DETERMINED THAT SOME ACCESS VITAMIN B12 REAGENT PACKS FROM LOT 439850 WERE NON-CONFORMING. A FIELD ACTION (FA-25021) WILL ADDRESS THE ISSUE. CUSTOMER'S ARE ADVISED TO STOP USE OF ACCESS VITAMIN B12 REAGENT KIT, PART NUMBER 33000, LOT NUMBER 439850. FOLLOW-UP MEDWATCH REPORT UPDATES SUMMARY: G6: FOLLOW-UP. H2: DEVICE EVALUATION. H6: - COMPONENT CODE 3050 DEVICE INGREDIENT OR REAGENT. - INVESTIGATION FINDINGS 170 MANUFACTURING PROCESS PROBLEM IDENTIFIED. - INVESTIGATION CONCLUSIONS 25 CAUSE TRACED TO MANUFACTURING. H11: CORRECTED DATA.

Description of Event or Problem

ON 03JAN2025 THE CUSTOMER REPORTED FALSE LOW VITAMIN B12 PATIENT RESULTS (ACCESS VITAMIN B12, PART NUMBER 33000 AND LOT NUMBER 439850) WERE GENERATED ON THE CUSTOMER'S DXI ANALYZERS (DXI 800 ACCESS IMMASSY W/SPOT B, PART NUMBER A71456 AND SERIAL NUMBERS (SN) (B)(6). THE CUSTOMER REPORTED THAT TWO PATIENTS HAD A CHANGE IN TREATMENT BASED ON THE FALSE LOW ACCESS VITAMIN B12 RESULTS. THIS REPORT WILL ADDRESS ONE OF THE TWO PATIENTS WITH A CHANGE IN TREATMENT. THIS PATIENT WAS PRESCRIBED VITAMIN B12 INJECTIONS BASED ON THE FALSE LOW ACCESS VITAMIN B12 RESULT OBTAINED ON (B)(6) 2024. HOWEVER, IT IS UNKNOWN IF SOME INJECTION WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. THE INITIAL VITAMIN B12 PATIENT RESULT WAS 66.4 PMOL/L ON DXI SN (B)(6) ON (B)(6) 2024, REPEATED AT >1106.7 PMOL/L. PATIENT RESULT WAS AMENDED. THE CUSTOMER'S VITAMIN B12 REFERENCE RANGE WAS 115-1000 PMOL/L. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS INCIDENT. SYSTEM CHECK DATA WAS NOT PROVIDED. CALIBRATIONS PASSED WITH REAGENT LOT 439850 ON BOTH INSTRUMENTS. THE FIELD APPLICATION SPECIALIST (FAS) ANALYZED QUALITY CONTROL (QC) DATA AND FOUND THAT THE 3 LEVELS OF QC RAN ON BOTH DXI INSTRUMENTS WERE ERRATIC WITH HIGH %CV AND OUTSIDE HIGH OR LOW SD VALUES. THE CUSTOMER STATED SOME HIGH VITB12 QC RESULTS WERE >1134 WITH ¿NO VALUE¿. MOST OF QUESTIONED QC RESULTS WERE OBTAINED ON VITB12 REAGENT LOT 439850. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. NOTE: A SECOND MEDWATCH REPORT WILL ADDRESS THE SECOND PATIENT WITH CHANGE IN TREATMENT.

Additional Manufacturer Narrative

A1: THE FULL PATIENT IDENTIFIER IS (B)(4). A2, A3, A4 AND A5: THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. H3 AND H6: NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. THE LOCAL SUPPORT ADVISED THE CUSTOMER TO STOP USING THE REAGENT LOT 439850 AND HELPED THE CUSTOMER TO MONITOR AND REPEAT PATIENT RESULTS. THE ISSUE IS CURRENTLY ESCALATED TO GLOBAL PRODUCT TECHNICAL SUPPORT (GPTS) AND TO TECHNICAL OPERATIONS TEAM SUPPORT (TOTS). AN INTERNAL INVESTIGATION WILL BE PERFORMED ON THE ACCESS VITAMIN B12 REAGENT PART NUMBER 33000, REAGENT LOT 439850. IN CONCLUSION, TO DATE, THE EXACT CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE INFORMATION SUPPLIED. TO DATE, THERE IS NO CONFIRMED MALFUNCTION OF THE REAGENT. NOTE: A SECOND MEDWATCH REPORT WILL ADDRESS THE SECOND PATIENT WITH CHANGE IN TREATMENT.