MAUDE Adverse Event Report: BECKMAN COULTER, INC ACCESS PROGESTERONE; RADIOIMMUNOASSAY, PROGESTERONE

Catalog Number	33550
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: full patient identifier is (b)(4).A2, a4 and a5: the customer did not provide patient demographics such as age, date of birth, weight, ethnicity or race.H3 and h6: the access progesterone reagent was not returned for evaluation.No hardware errors, flags or other assay issues 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 issues with sample integrity were reported by the customer.The customer technical support (cts) called customer back upon data reviewed and explained that hardware was verified with passing system checks and precision run is well within expectations of the progesterone assay.Then cts discussed with customer preanalytical factors and sample handling could potentially be the cause of issue.Cts will send customer letter for hardware verification and preanalytical factors hand out for sample handling.The cts sent a box of calibrator and two boxes of progesterone ii reagent to customer since they were interested in switching consumables.In conclusion, the cause of the issue could not be determined with the available 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 erroneously elevated progesterone patients' results were generated on the customer's access 2 immunoassay analyzer (part number 81600n and serial number (b)(6).Due to false high access results, the embryo transfer for the ivf (invitro fertilization) procedure was cancelled for one patient.No further information was provided.The customer reported that they questioned progesterone results that were greater than 2 ng/ml while the clinical expected results should be close to 0 ng/ml.No specific data for this patient was provided by the customer.The customer sent out the samples to another laboratory and the results came back around 0.6 ng/ml.No hardware errors or issues with other assays were reported in conjunction with this event.System checks passed on 14mar2025,22mar2025 and 31mar2025.Calibration completed on 25mar2025 and 14mar2025 with reagent lot with 440455 and calibrator lot 440099 passed.Quality controls (qc) were passing within the laboratory¿s established ranges at the time of the event.Weekly maintenance is performed normally on fridays.Precision run passed with a 3.88 % cv within imprecision claim of total imprecision less than 9%.The customer technical support (cts) reviewed data with customer.No issues with sample integrity were reported.Samples were collected in sst tiger top, centrifuged at ~15-30 minutes after collection at 3200 rpm for 6 min at room temperature and poured off into 14ml snap top tube.

• Brand Name: ACCESS PROGESTERONE
• Common Device Name: RADIOIMMUNOASSAY, PROGESTERONE
• 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: 21900202
• Report Number: 2122870-2025-00078
• Device Sequence Number: 17158704
• Product Code: JLS
• UDI-Device Identifier: 15099590231378
• UDI-Public: (01)15099590231378(17)260531(11)241207(10)440455
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K955769
• 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): 04/24/2025

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: 05/31/2026
• Device Catalogue Number: 33550
• Device Lot Number: 440455
• 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: 04/03/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2024
• 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: Female