MAUDE Adverse Event Report: BECKMAN COULTER ACCESS FREE T4; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number	33880
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024 the customer reported obtaining erroneously elevated free t4 results for one patient involving the laboratory's access 2 immunoassay analyzer (serial number (b)(6).The customer provided the following free t4 results (the free t4 customer reference ranges are 0.6-1.6 ng/dl).The first questioned sample free t4 result for this patient was 4.8 ng/dl on (b)(6) 2023.This sample was tested on an alternate instrument with a result at 1.5 (unit not provided).Sample 2 free t4 result was 2.85 ng/dl on (b)(6) 2024.This sample was tested on an alternate instrument with a result at 0.91 (unit not provided).Sample 3 free t4 result was 2.29 ng/dl on (b)(6) 2024.This sample was tested on an alternate instrument with a result at 0.63 (unit not provided).Sample 4 free t4 result was 1.66 ng/dl on (b)(6) 2024.This sample 4 was tested using heterophile blocking tube with a free t4 result at 2.1 ng/dl.This sample was also tested on an alternate instrument with a result at 0.61 (unit not provided).Sample 5 free t4 result was 1.01 ng/dl on (b)(6) 2024.This sample 5 was tested on an alternate instrument with a result at 1.45 (unit not provided).Sample 6 free t4 result was 4.94 ng/dl on (b)(6) 2024.This sample 6 was tested using heterophile blocking tube with a free t4 result at 4.86 ng/dl.This sample was also tested on an alternate instrument with a result at 1.48 (unit not provided).The customer reported a delay in patient treatment.The customer reported that doctor looks at test results and prescribes medication on the same day.Due to the questioned results, patient samples are sent to an external testing laboratory and the results are provided one day later.No hardware errors were reported in conjunction with this event.Calibration passed on 20mar2024 with reagent lot 338710 and calibrator lot 338395.No quality control data was provided.No issues with samples integrity were reported by the customer.Note: the customer reported that the access total t3 results for this patient were also questioned.A second medwatch report will address the questioned total t3 results for this patient.
Additional Manufacturer Narrative
A1: the full patient identifier is (b)(6).A2, a3, a4 and a5: the customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.H3 and h6: the access free t4 reagent was not returned for evaluation.No hardware errors, flags were reported in conjunction with this event.No issues with samples integrity were reported by the customer.Service was dispatched.Field service engineer (fse) replaced reagent and calibrator pack.The fse also tested some samples using heterophile blocking tubes but the results were unchanged.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.Note 1: a second medwatch report will address the questioned total t3 results for this patient.Note 2: a second patient with questioned free t4 and total t3 results was reported on (b)(6) 2024.Two other medwatch reports will address the questioned total t3 and free t4 results for this second patient.

• Brand Name: ACCESS FREE T4
• Common Device Name: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 19309561
• Report Number: 2122870-2024-00018
• Device Sequence Number: 3077157
• Product Code: CEC
• UDI-Device Identifier: 15099590225834
• UDI-Public: (01)15099590225834(17)250831(11)230901(10)338710
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K240273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

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: 08/31/2025
• Device Catalogue Number: 33880
• Device Lot Number: 338710
• 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: 04/21/2024
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• 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