MAUDE Adverse Event Report: Beckman Coulter, Inc Access TSH (3rd IS); radioimmunoassay, thyroid-stimulating hormone

Catalog Number	B63284
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported questioning elevated access tsh (3rd is) results for one patient involving the laboratory's unicel dxi 800 access immunoassay analyzer (serial number (b)(6)).The customer reported that the access tsh results were discordant with the roche cobas results.The patient was draw on (b)(6) 2026 and sample was kept refrigerated until testing on (b)(6) 2026.The access result for tsh was 17.01 uiu/ml.On (b)(6) 2026, the patient was recollected and tested on roche cobas with a sample result at 3.75 uiu/ml.On (b)(6) 2026, the initial sample was retested with a similar access result of 17.17 uiu/ml.The patient was redrawn on (b)(6) 2026, and tested on (b)(6) 2026 with an access result of 7.27 uiu/ml, repeated at 7.25 uiu/ml on (b)(6) 2026.These results were obtained after the patient had been taking the medication for approximately 30 days.The patient had no documented history of hypothyroidism.On (b)(6), the physician prescribed 25 µg of synthroid.No additional adverse patient impact was reported.No hardware errors and other assay issues were reported in conjunction with this event.Per originator's verbal report, system performance indicators were passing within specifications at the time of the event.The sample was noted to not have any hemolysis, icterus or lipemia.Cts (customer technical support) advised checking for a patient sample identification mismatch related to the high results, but none was found.A beckman coulter laboratory solution specialist (lss) was dispatched to customer site on (b)(6) 2024.
Additional Manufacturer Narrative
A1: the full patient identifier is (b)(6).A2, a4 and a5: the customer did not supply patient demographics such as age, date of birth, weight, ethnicity or race.H3 and h6: - no hardware errors and 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 other patient results were called into question.- no issues with sample integrity were reported by the customer.- cts (customer technical support) advised checking for a patient sample identification mismatch related to the high results, but none was found.- customer sent the sample for interference testing to chaska chu (complaint handling unit).Chu performed the testing and obtained a similar neat result of 6.6 mlu/l and did not found any interference with the patient sample.- no further issue was reported by the customer.In conclusion, a definitive cause for this issue cannot be determined with the available information.

• Brand Name: Access TSH (3rd IS)
• Common Device Name: radioimmunoassay, thyroid-stimulating hormone
• 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: 50946406
• Report Number: 2122870-2026-00390
• Device Sequence Number: 21238587
• Product Code: JLW
• UDI-Device Identifier: 15099590671495
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153651
• 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): 09/30/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: B63284
• Device Lot Number: 633354
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2026
• 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
• Patient Sex: Unknown