ACCESS VITAMIN B12

Additional Manufacturer Narrative

A1: THE FULL PATIENT IDENTIFIER IS (B)(4). A2, A3, A4 AND A5/A6: THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS DATE OF BIRTH, WEIGHT, ETHNICITY OR RACE. H3 AND H6: THERE WERE NO HARDWARE ERRORS OR OTHER FLAGS REPORTED AT THE TIME OF THE EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. HIGH TITERS OF INTRINSIC FACTOR ACTIVITY AND PARIETAL CELL ANTIBODIES AND VITAMIN B12 DEFICIENCY WERE FOUND ON (B)(6) 2025. PER THE ACCESS VITAMIN B12 INSTRUCTIONS FOR USE (IFU) AVAILABLE ON THE BECKMAN COULTER WEBSITE, IT STATES: ¿APPROXIMATELY 50% OF PATIENTS WITH PERNICIOUS ANEMIA HAVE INTRINSIC FACTOR ANTIBODIES. THE INITIAL DENATURATION STEP IN THE ACCESS VITAMIN B12 ASSAY INACTIVATES INTRINSIC FACTOR BLOCKING ANTIBODIES. HOWEVER, IN VERY RARE CASES, SOME SAMPLES MAY NOT BE INACTIVATED DUE TO THE HETEROGENEITY OR EXTREMELY HIGH TITER OF THE INTRINSIC FACTOR ANTIBODIES. SUCH INTERFERING ANTIBODIES MAY CAUSE ERRONEOUS RESULTS. PATIENTS SHOULD BE FURTHER EVALUATED IF SUSPECTED OF HAVING THESE ANTIBODIES OR IF THE VITAMIN B12 RESULTS ARE IN CONFLICT WITH OTHER CLINICAL OR LABORATORY FINDINGS. ¿ ¿THE ACCESS VITAMIN B12 RESULTS SHOULD BE INTERPRETED IN LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PATIENT, INCLUDING SYMPTOMS, CLINICAL HISTORY, DATA FROM ADDITIONAL TESTS AND OTHER APPROPRIATE INFORMATION.¿ IN CONCLUSION, THE LIKELY CAUSE OF THIS ISSUE IS AN INTERFERENCE WITH INTRINSIC FACTOR ANTIBODIES. THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT A MALFUNCTION OCCURRED IN CONJUNCTION WITH THIS EVENT. NOTE: THIS MEDWATCH REPORT ADDRESSES THE UNNECESSARY BONE MARROW BIOPSY PERFORMED ON (B)(6) 2025 (B)(4). A SECOND MEDWATCH REPORT WILL ADDRESS THE DELAY IN PATIENT TREATMENT (B)(4).

Description of Event or Problem

ON (B)(6) 2026 THE CUSTOMER REPORTED REPEATABLE FALSE ELEVATED (WITHIN NORMAL RANGE) VITAMIN B12 (ACCESS VITAMIN B12 COBALAMIN ¿ PART NUMBER 33000) RESULTS FOR ONE PATIENT ON THEIR DXI 9000 ANALYZERS SERIAL NUMBER (B)(6). THE PATIENT WAS INITIALLY INVESTIGATED AS PROBABLE MYELODYSPLASIA, AS PATIENT PRESENTED WITH MACROCYTIC ANEMIA AND NORMAL ACCESS VITAMIN B12, FOLATE, THYROID FUNCTION AND LIVER FUNCTION. ACCESS VITAMIN B12 WAS REPEATEDLY MEASURED, AND IT WAS CONSISTENTLY IN THE NORMAL REFERENCE RANGE (SEE BELOW). ON (B)(6) 2025, THE PATIENT UNDERWENT A BONE MARROW BIOPSY WHICH SHOWED SOME DYSPLASIA BUT DID NOT HAVE ANY TYPICAL FEATURES OF MYELODYSPLASTIC SYNDROME. THIS MEDWATCH REPORT ADDRESSES THE UNNECESSARY BONE MARROW BIOPSY. ON (B)(6) 2025, FURTHER INVESTIGATION LED TO FIND HIGH TITERS OF INTRINSIC FACTOR ACTIVITY AND PARIETAL CELL ANTIBODIES AND VITAMIN B12 DEFICIENCY. THE PATIENT HAD REPLACEMENT THERAPY ON (B)(6) 2025. A SECOND MEDWATCH REPORT WILL ADDRESS THE DELAY IN PATIENT TREATMENT (B)(4). THERE WERE NO HARDWARE ERRORS OR OTHER FLAGS REPORTED AT THE TIME OF THE EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS AUTOMATIC SYSTEM DIAGNOSTICS, CALIBRATION AND QUALITY CONTROL WERE NOT PROVIDED FOR REVIEW. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. NO SAMPLE COLLECTION OR PROCESSING INFORMATION WAS PROVIDED BY THE CUSTOMER.