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

Catalog Number	33000
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
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.

• 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: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 21240292
• Report Number: 2122870-2025-00055
• Device Sequence Number: 3663995
• Product Code: CDD
• UDI-Device Identifier: 15099590224301
• UDI-Public: (01)15099590224301(17)250630(11)240630(10)439850
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 02/26/2025

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: 06/30/2025
• Device Catalogue Number: 33000
• Device Lot Number: 439850
• 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: 01/03/2025
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2024
• 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 Sex: Unknown