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

Model Number 33880

Device Problem Low Test Results (2458)

Patient Problem Insufficient Information (4580)

Event Date 08/31/2021

Event Type  Injury  

Manufacturer Narrative

Patient id: the full identifier for this event is (b)(6).The customer did not provide patient demographics such as age, date of birth, sex, 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 calibration and quality control were within specifications at the time of the event.The customer reported the questioned low free t4 results occurred with two reagent lots: lot 124403 and lot 124082.Reagent lot 124082 is addressed in (b)(6).In conclusion, the cause of this event cannot be determined with the available information.

Event Description

On (b)(6) 2021 the customer reported questioned low free t4 (access free t4, part number 33880 and lot number 124403) were generated on the customer's dxi (dxi 800 access immunoassay analyzer, part number 973100 and serial number (b)(4)) for an undisclosed number of patients.Customer provided a list of results; however, customer did not indicate which results were considered questioned low and also did not indicate which results were associated with change to patient management.The low free t4 results were released from the laboratory.The customer reported they sent samples to a reference lab to be tested using the reference lab's access 2.Customer reported they considered these result to be similar to the results generated on the customer's dxi.There was a report of a change to patient management in association with this event.The customer reported the physician was delaying treatment for the patients due to the questioned low free t4 results.There was no additional information provided regarding treatment of the patients.No hardware errors or issues with other assays 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.Sample collection, handling and storage information such as sample type, volumes drawn, centrifugation time and speed, sample storage or other sample information was not 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 ; 5523681224
• MDR Report Key: 12527237
• MDR Text Key: 273764193
• Report Number: 2122870-2021-00155
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 15099590225834
• UDI-Public: (01)15099590225834(17)230531(11)210531(10)124403
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 33880
• Device Catalogue Number: 33880
• Device Lot Number: 124403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• 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