MAUDE Adverse Event Report: Beckman Coulter, Inc ACCESS 2 IMMUNOASSAY ANALYZER; analyzer, chemistry (photometric, discrete), for clinical use

Catalog Number	81600N
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: the full patient identifier is (b)(6).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: as part of the investigation, the lss corrected the hstni sample unit configuration.After the sample units were modified to the appropriate setting, hstni results returned to expected values, confirming normal assay performance.Beckman coulter product security was also consulted regarding the modified apf software; however, the review did not confirm a product cybersecurity event or incident.The investigation concluded that the cause of the event was user error, as the customer did not ensure consistency between plasma and serum sample unit settings and did not recognize the unit discrepancy when reviewing results.The issue was resolved through correction of the assay unit settings, the customer accepted the resolution, and no further action was required.Retrospective mdr submission under capa-001570.The complaint was reassessed using beckman coulter's revised mdr malfunction reportability methodology and was determined to be reportable.This report is being submitted as part of capa-001570 remediation activities.
Event or Problem Description
The customer reported receiving unexpectedly high access hstni (part number b52699) patient results on an access 2 analyzer (serial number (b)(6)).No adverse patient impact, injury, exposure, misdiagnosis, or mistreatment was reported in connection with this event.Following the complaint, a beckman coulter laboratory solution specialist (lss) was dispatched to investigate the issue.During troubleshooting, the lss learned that the elevated hstni results occurred after testing a bnp assay that utilized a third-party reagent.Further investigation determined that the apf software modified by the third-party manufacturer was being used for bnp testing.The bnp assay was configured to use plasma units (pg/ml), while the hstni assay was configured to use serum units (ng/ml).The investigation found that after bnp testing was performed, the hstni assay unit setting changed from serum units (ng/ml) to plasma units (pg/ml).The customer did not recognize this unit change when reviewing results and did not convert the plasma-based results to the appropriate serum units, leading to the perception of falsely elevated hstni results.No hardware errors, assay-specific performance issues, or other system-related problems were reported.System performance data, including system checks, calibration, and quality control results at the time of the event, were not available for review.

• Brand Name: ACCESS 2 IMMUNOASSAY ANALYZER
• Common Device Name: analyzer, chemistry (photometric, discrete), for clinical use
• 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 55318 ; +1(952)491-6938
• MDR Report Key: 50856719
• Report Number: 2122870-2026-00226
• Device Sequence Number: 9652061
• Product Code: JJE
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K172787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• 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): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 81600N
• 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: 12/08/2024
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2019
• 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
• Patient Sex: Unknown