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

Model Number 33880

Device Problem High Test Results (2457)

Patient Problem Insufficient Information (4580)

Event Date 03/11/2022

Event Type  Injury  

Manufacturer Narrative

The full patient identifier for this event is (b)(4).The customer did not provide patient demographics such as age, date of birth, patient weight, ethnicity or race.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.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.The patient sample was tested by the beckman coulter complaint handling unit (chu).The testing did not demonstrate the presence of a patient-sourced interferent in the patient sample.In conclusion, the cause of this event cannot be determined with the available information.

Event Description

The customer reported that a questioned high free t4 (access free t4, part number 33880 and lot number 125435) was generated on the customer's access 2 (access 2 immunoassay analyzer, part number 81600n and serial number (b)(4)) for one patient.The result was reported out of the lab.There was a change to patient treatment or management which occurred in connection with this event.The customer-provided information indicated the patient's synthroid dose was decreased from 175 ug to 150 ug.No report of additional changes to patient treatment or management were provided.No hardware errors or issues with other assays were reported in conjunction with this event.No other patient results were called into question.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.The customer reported they previously had investigative interference testing performed by beckman coulter for the patient in this event.The customer reported the patient had a history of tsh3 value of 0.31 uiu/ml and free t4 value of 1.7 ng/dl.Investigator review of historical data shows the sample from (b)(6) 2021 was returned to the complaint handling unit for investigative interference testing.The presence of an interferent could not be confirmed at that time.Sample was collected in a lithium heparinized plasma gel separator tube, centrifuged for 5 minutes at 5000 revolutions per minute (rpm).Sample was noted to be a good specimen; clear, straw colored plasma.No other sample collection or processing information was provided.

• Brand Name: ACCESS FREE T4 REAGENT
• 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 ; 7149613625
• MDR Report Key: 13966015
• MDR Text Key: 288305960
• Report Number: 2122870-2022-00017
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 15099590225834
• UDI-Public: (01)15099590225834(17)231130(11)211130(10)125435
• 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: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 33880
• Device Catalogue Number: 33880
• Device Lot Number: 125435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2021
• 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