MAUDE Adverse Event Report: Beckman Coulter, Inc. Access Thyroglobulin; System, Test, Thyroglobulin

Catalog Number	33860
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, the customer reported false positive access thyroglobulin (part number: 33860; lot number: 539320) were generated on their dxi 800 access instrument (part number: a71456; serial number: (b)(6).There was a change to patient management reported for two patients.One patient had false positive results reported outside the laboratory and underwent imaging, including ultrasound and uptake scans.There was no report of further harm to the patient as a result of the change in treatment.Note: as two patients were involved, two medwatch reports will be submitted, one for each patient.The customer elaborated that they had noticed increased positive results and discrepancies with lc-ms, mass spec results.The negativity rate had dropped significantly.The customer stated the questioned results started on (b)(6) 2026 and after retrospective review, the doctor confirmed the two patients which had undergone imaging that they would not have needed otherwise.No other assay or hardware issues were reported in conjunction with this event.Quality controls were passing within the laboratories established means calibration passed on (b)(6) 2026 using reagent lot 539320 and calibrator lot 538937.The customer stated no issues with sample integrity as each sample is manually loaded and integrity is checked on each one.
Additional Manufacturer Narrative
A1: the full identifier is (b)(4).A2, a3, a4 and a5: the customer did not provide patient demographics such as age, gender, date of birth, weight, ethnicity or race.H3 and h6: the access thyroglobulin reagent was not returned for evaluation.There were no reports of system issues at the time of the event.No hardware errors or flags were reported in conjunction with the event.Calibration and quality controls were passing at the time of the event.The customer noted that they received a new reagent lot 633238 on 24-june-2026 and the lot to lot comparison have been much lower by 60% on this new lot 633238 and not matching with previous reagent lot 539320.The customer was sent replacement thyroglobulin reagent.The customer has not called for any further assistance and were satisfied with the assistance provided.In conclusion, a cause for this event cannot be determined with the available information.There is no evidence to suggest a reagent malfunction was the cause of this event.

• Brand Name: Access Thyroglobulin
• Common Device Name: System, Test, Thyroglobulin
• 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: 50012372
• Report Number: 2122870-2026-00026
• Device Sequence Number: 10579210
• Product Code: MSW
• UDI-Device Identifier: 15099590227173
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K031269
• 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): 07/23/2026

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: 33860
• Device Lot Number: 539320
• 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: 06/26/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2025
• 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