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

Catalog Number 33880

Device Problem Low Test Results (2458)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/20/2024

Event Type  Injury  

Manufacturer Narrative

A1: full patient identifier is (b)(4).H3 and h6: the access free t4 reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.A beckman coulter field service engineer (fse) assisted the customer over the phone.Fse suggested the customer recalibrate with new reagent packs.Customer performed recalibration with new reagent packs and reported that patient samples run after the recalibration were back in expected ranged.The customer was satisfied with the resolution.In conclusion, the cause of the event cannot be determined with the available information.

Event Description

The customer reported obtaining erroneous low free t4 (access free t4, part number 33880 and lot number 339067) results on the customer's access 2 (access 2 immunoassay analyzer, part number 81600n and serial number (b)(6)) for one patient.The erroneous low free t4 result was released from the laboratory.There was a report of change to patient treatment or management which occurred in connection with this event.The customer reported the patient had a surgery scheduled which was delayed due to the low free t4 results.There was no further report of injury or change to patient management.Initial results of 0.32 and 0.39 ng/dl were obtained.The same sample was sent to another laboratory using an alternate methodology and the results were 1.0 and 1.83 ng/dl.The customer stated the alternate laboratory's methodology was eclia; however, the customer did not know what instrument or platform was used.No hardware errors, flags or other assay issues were reported.System performance indicators have been passing within specification.There were no issues with sample integrity reported by the customer.

• Brand Name: ACCESS FREE T4
• Type of Device: 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 92821-8000 ; 7149613625
• MDR Report Key: 19047404
• MDR Text Key: 339435371
• Report Number: 2122870-2024-00016
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 15099590225834
• UDI-Public: (01)15099590225834(17)260131(11)240201(10)339067
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/04/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 33880
• Device Lot Number: 339067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other