MAUDE Adverse Event Report: Beckman Coulter, Inc Access High Sensitivity Troponin I reagent; Immunoassay Method, Troponin Subunit

Catalog Number	B52699
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2025
Type of Reportable Event	Malfunction

• Brand Name: Access High Sensitivity Troponin I reagent
• Common Device Name: Immunoassay Method, Troponin Subunit
• 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 ; +1(952)491-6938
• MDR Report Key: 50932284
• Report Number: 2122870-2026-00354
• Device Sequence Number: 10722293
• Product Code: MMI
• UDI-Device Identifier: 15099590693183
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K172787
• 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): 09/29/2026

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 Expiration Date: 10/31/2025
• Device Catalogue Number: B52699
• Device Lot Number: 440362
• 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: 02/23/2025
• Initial Report FDA Received Date: 09/29/2026
• 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
• Patient Sex: Unknown