MAUDE Adverse Event Report: BECKMAN COULTER, INC ACCESS VITAMIN B12; RADIOASSAY, VITAMIN B12

Catalog Number	33000
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(60 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.The unnecessary bone marrow biopsy has been addressed in a previous medwatch report (b)(4).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.This medwatch report will address the delay in patient treatment.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.
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 delay in patient treatment (b)(4).A second medwatch report address the unnecessary bone marrow biopsy performed on (b)(6) 2025 (b)(4).

• Brand Name: ACCESS VITAMIN B12
• Common Device Name: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BECKMAN COULTER, INC; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER, INC; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 24854896
• Report Number: 2122870-2026-00013
• Device Sequence Number: 21091563
• Product Code: CDD
• UDI-Device Identifier: 15099590224301
• UDI-Public: (01)15099590224301(17)251031(11)241031(10)440318
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K223289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 33000
• Device Lot Number: 440318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Male