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	10/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the customer reported obtaining reproducible false elevated progesterone (access progesterone reagent part number 33550, lot number 538591) patient results on their access 2 analyzer serial number (sn) (b)(6).A change to patient treatment/management was reported in connection with this event.One patient had her infertility cycle cancelled as a result of the initial elevated result.The sample patient progesterone results were at 1.21 ng/dl, repeated at 1.28 ng/ml on (b)(6) 2025.The results were questioned by physicians as higher than the patient clinical picture.The same sample was retested at the main/reference lab at <0.5 ng/dl (unknown method).No hardware errors or issues with other assays were reported in conjunction with this event.System check was performed on (b)(6) 2025 and passed within specifications.Quality control (qc) material has been passing within the laboratory¿s established ranges.No issues with sample integrity were reported by the customer.Sample is collected in 5ml sst gold top tube, run fresh and centrifuged at 2900 rpm for 15 mins at room temperature.Sample was transported to the reference lab approximately 3 hours later in a cooler.
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 performed a precision testing for progesterone with a resulting %cv of 12.4% which is within the expected variability of the assay.Customer technical support (cts) discussed the role of pre-analytical factors and sample handling and will provide these documents to customer via email.Customer will continue to monitor and plans on carrying out a patient correlation between their lab and the main/reference lab in the coming weeks.If any issues with the correlation, customer will call hotline.No further issue was reported.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.

• 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: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 23618513
• Report Number: 2122870-2025-00111
• Device Sequence Number: 18405072
• Product Code: JLS
• UDI-Device Identifier: 15099590231378
• UDI-Public: (01)15099590231378(17)261130(11)250608(10)538591
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/21/2025

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 Catalogue Number: 33550
• Device Lot Number: 538591
• 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: 11/04/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2025
• 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