MAUDE Adverse Event Report: BECKMAN COULTER, INC ACCESS PTH; RADIOIMMUNOASSAY, PARATHYROID HORMONE

Catalog Number	A16972
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: the full patient identifier is (b)(4).A2, a3, a4, and a5: the customer did not supply patient demographics such as age, weight, height, gender, ethnicity or race.H3 and h6: the pth reagent was not returned for evaluation.Customer technical support (cts) reviewed instrument performance and compared qc results to bio-rad unity performance; the instrument remained within acceptance limits.A field application specialist (fas) provided further support to the customer.Qc results were reviewed with the customer, and it was confirmed that qc results were within acceptable range compared to biorad e-insert, biorad unity, and past 30 days performance.The customer indicated that they may review and adjust qc ranges.In conclusion, the cause of this event cannot 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) 2026.The customer reported a delay to patient treatment due to quality control (qc) failure for the access pthio assay (parathyroid hormone reagent part: a16972, lot number: 539221) on their dxi 9000 immunoassay analyzer (part number: c11137, serial number: (b)(6) for one patient.The customer stated that a surgical procedure was delayed approximately 60 minutes, with no further impact to the patient.No death or injury occurred.The qc data provided demonstrates that level 1 and level 2 qc were within laboratory¿s established ranges since on (b)(6) 2026, with values being within 1 standard deviation (sd).Level 3 qc was on the higher side of the customer¿s range on (b)(6) 2026 with values close to 2sd, but still within ranges.No hardware or other assay issues were reported in conjunction with this event.No system performance indicators such as system check and calibration were provided for review.No issues with sample integrity were reported by the customer.

• Brand Name: ACCESS PTH
• Common Device Name: RADIOIMMUNOASSAY, PARATHYROID HORMONE
• Manufacturer (Section D): BECKMAN COULTER, INC; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER, INC.; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska 55318 ; 9524916938
• MDR Report Key: 24743945
• Report Number: 2122870-2026-00008
• Device Sequence Number: 21027671
• Product Code: CEW
• UDI-Device Identifier: 15099590201937
• UDI-Public: (01)15099590201937(17)261130(11)251130(10)539221
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K061190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: A16972
• Device Lot Number: 539221
• 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: 03/04/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2025
• 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: Unknown