MAUDE Adverse Event Report: BECKMAN COULTER, INC ACCESS B-TYPE NATRIURETIC PEPTIDE; TEST, NATRIURETIC PEPTIDE

Catalog Number	98200
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 17mar2026, the customer reported inconsistent bnp results (part number 98200, lot number 538343) for one patient involving their unicel dxi 800 instrument (part number a71456 and serial number (s/n) (b)(6).Customer stated patient was being treated and was "given a bunch of meds" based on the 793 pg/ml result.No further injury to patient was reported.No further information was provided.On (b)(6) 2026, the initial bnp result was 39 pg/ml (05:05 am) on the dxi 800 s/n (b)(6).Another aliquot from the same primary tube was spun down 5 hours later and run on the dxi 800 analyzer (serial number (b)(6), resulting in 793.3 pg/ml (result questioned) (10:22 am).A third sample was drawn, aliquoted, spun down, and run on the analyzer serial number (b)(6), resulting in 104.7 pg/ml.All results were released from laboratory.No hardware errors or issues with other assays were reported in conjunction with this event.System check data was not provided.Calibration passed on 01mar2026 using reagent lot 538343 calibrator lot 538891.Quality control passed within specifications prior to and after the event.Patient sample type was lavender edta tube.No further information was provided.
Additional Manufacturer Narrative
A1: the full patient identifier is case (b)(4).A2, a3, a4, a5 and a6: the customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.H3 and h6: no hardware errors or issues with other assays were reported in conjunction with this event.System performance indicators such as calibration and quality control were passing within specifications at the time of the event.No other patient results were called into question.The issue is sample specific.¿ cts (customer technical support) and customer discussed on potential sample handling issue, like insufficient tube draw or improper cell separation, could lead to such discrepancies.In conclusion, the cause of this event cannot be determined with the available information.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.

• Brand Name: ACCESS B-TYPE NATRIURETIC PEPTIDE
• Common Device Name: TEST, NATRIURETIC PEPTIDE
• 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: 24713208
• Report Number: 2122870-2026-00007
• Device Sequence Number: 5763039
• Product Code: NBC
• UDI-Device Identifier: 15099590750947
• UDI-Public: (01)15099590750947(17)260531(11)250531(10)538343
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K232164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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: 05/31/2026
• Device Catalogue Number: 98200
• Device Lot Number: 538343
• 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: 03/16/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2025
• 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