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	01/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: the full patient identifier is (b)(4).A5: the customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity, or race.H3 and h6: the access bnp (access b-type natriuretic peptide) reagent was not returned for evaluation.No hardware errors or issues with other assays were reported in conjunction with this event.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.No other patient results were called into question.A field applications specialist (fas) reviewed the sample history, calibration, qc, and system check data from the instrument.The fas noted that there was no evidence of a hardware malfunction and no flags were generated on the sample when the instrument generated the result.In conclusion, the likely cause for this event cannot be determined with the provided information.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.
Event or Problem Description
On (b)(6) 2025, the customer reported erroneous elevated access bnp (access b-type natriuretic peptide, part number 98200, lot number 439890) were generated on the customer¿s dxi 800 access immunoassay w/spot b analyzer (part number a71456, serial number (b)(6) for one patient.The patient¿s initial sample generated an elevated result of 774 pmol/l on (b)(6) 2025.The patient was reported to be admitted to the hospital where additional testing was performed and did not show any abnormality.The additional testing performed is not known and was verbally stated to be ¿an echo and a cardiothoracic scan¿.There was no further report of injury of affect to the patient.An additional sample was collected from the patient and produced a result of 9 pmol/l on (b)(6) 2025.The original sample was re-run, although past the recommended stability) and produced a result of 8 pmol/l on (b)(6) 2025.No hardware errors or issues with other assays were reported in conjunction with this event.System check passed on (b)(6) 2025.Calibration passed on (b)(6) 2024 with reagent lot 439890 and calibrator lot 439218.Quality control (qc) was passing within the laboratory¿s established ranges.No other patient results were called into question.No issues with sample integrity were reported by the customer.

• 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: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 21365885
• Report Number: 2122870-2025-00057
• Device Sequence Number: 8452721
• Product Code: NBC
• UDI-Device Identifier: 15099590750947
• UDI-Public: (01)15099590750947(17)250831(11)240831(10)439890
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K232164
• 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): 02/12/2025

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: 08/31/2025
• Device Catalogue Number: 98200
• Device Lot Number: 439890
• 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: 01/22/2025
• Initial Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown