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 10/22/2021

Event Type  Injury  

Event Description

On (b)(6) 2021 the customer reported that a questioned high free t4 (access free t4, part number 33880 and lot number 124928) 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.The customer also provided previous free t4 results which had been generated for this patient; however, the customer did not indicate whether the previous free t4 results were questioned.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 200 ug to 175 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.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.

Manufacturer Narrative

(b)(6).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

On 25oct2021 the customer reported that on (b)(6) 2021, a questioned high free t4 (access free t4, part number 33880 and lot number 124928) was generated on the customer's access 2 (access 2 immunoassay analyzer, part number 81600n and serial number (b)(6)) for one patient.The result was reported out of the lab.The customer also provided previous free t4 results which had been generated for this patient; however, the customer did not indicate whether the previous free t4 results were questioned.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 200 ug to 175 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.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: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12853056
• MDR Text Key: 281092570
• Report Number: 2122870-2021-00171
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 15099590225834
• UDI-Public: (01)15099590225834(17)230731(11)210731(10)124928
• 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,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 33880
• Device Catalogue Number: 33880
• Device Lot Number: 124928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male