MAUDE Adverse Event Report: BECKMAN COULTER, INC ACCESS ACCUTNI+3 REAGENT; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number	A98143
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: the full patient identifier is (b)(6).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: available performance indicators at the time of the event such as passing system check and overall quality control performance within specifications did not indicate any issue with the system.¿ the customer was advised to perform instrument verification which included system check and precision testing.The result of the precision test was a standard deviation of 0.002 ng/ml which is within the expected variability of the assay per the accu tni +3 instructions for use (
Event or Problem Description
On (b)(6) 2025 the customer reported obtaining erroneous elevated troponin i (access accutni+3) results for twenty patients involving the laboratory's access 2 immunoassay analyzer (serial number s/n (b)(6)).The customer reported that four (4) patients had changed treatment due to the initial false high results.No further information regarding the change in treatment was provided.This report address the patient 2 on 4.No hardware errors or issues with other assays were reported in conjunction with this event.System check was performed (b)(6) 2025 and initially failed for unwashed %cv at 2.01 % (range 0.00 ¿ 2.00%).When repeated it passed within specifications.Calibration passed on 04oct2025 with reagent lot 440416 and calibrator lot 440251.Quality control (qc) was passing within the laboratory¿s established ranges.There was no evidence to suggest carryover as the customer did not report running a sample of high troponin concentration prior to the questioned results.The customer provided the following erroneous elevated patient results for six patient samples.The initial elevated results (pack lot 440416) were repeated on the same access 2 instrument using a different reagent pack lot (538618).-initial/rerun results (all units ng/ml): -patient 1: 0.71/0.01.-patient 2: 1.20/0.09.-patient 3: 0.58/0.00.-patient 4: 0.76/0.01.-patient 5: 0.95/0.00.-patient 6: 1.03/0.22.It is unknown which of the above patient results (if any) were connected to the patients with changed treatment.Sample tube collection type was 3 ml lithium heparin "vacuette" 13x75 tubes.The customer reported that the sample was centrifuged for 10 minutes at ~3659¿4000 rpm at room temperature.There was no report of sample integrity issues no further sample information was provided.The customer was advised to perform instrument verification which included system check and precision testing.

• Brand Name: ACCESS ACCUTNI+3 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 ; 9524916938
• MDR Report Key: 23421918
• Report Number: 2122870-2025-00106
• Device Sequence Number: 12806605
• Product Code: MMI
• UDI-Device Identifier: 15099590209322
• UDI-Public: (01)15099590209322(17)251031(11)241031(10)440416
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121214
• 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): 10/30/2025

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: 10/31/2025
• Device Catalogue Number: A98143
• Device Lot Number: 440416
• 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: 10/08/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown