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

Model Number	33880
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age, sex, weight and ethnicity: the customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.Device evaluated by mfr: 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.Quality control was within specifications at the time of the event.Other system performance indicator information such as system checks or calibrations were not supplied.In conclusion, the cause of this event cannot be determined with the available information.
Event or Problem Description
On june 19th, 2019, the customer reported that on (b)(6) 2019, a questioned low access free t4 result of 0.9 (units not provided) had been generated on the customer¿s unicel dxi 600 immunoassay analyzer (part number a71460 and serial number (b)(4)) for one patient sample.The result was reported out of the lab.The customer also reported that there were previous dates that the patient had free t4 tested: on (b)(6) 2018, the patient had a free t4 result of 1 (units not provided) and on (b)(6) 2019, the patient had a free t4 result of 1 (units not provided).The customer did not provide the reference range.The customer reported a change to patient treatment which occurred in connection with this event.Details of this change to patient treatment were not provided.No report of additional changes to patient management were provided.Quality control results were passing within specifications at the time of the event.Other system performance indicator information such as system checks or calibrations were not supplied.There were no errors or events reported on the unicel dxi 600 immunoassay system at the time of the event.The sample was centrifuged at 3000 rpm for 8 minutes.The customer noted that the sample was a bd rst tube with thrombin-based clot activator and polymer gel.No other sample processing information was provided.

• Brand Name: ACCESS FREE T4 REAGENT
• Common Device Name: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 8794382
• Report Number: 2122870-2019-01094
• Device Sequence Number: 11257215
• Product Code: CEC
• UDI-Device Identifier: 15099590225834
• UDI-Public: (01)15099590225834(17)210228(11)190301(10)920749
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K982250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2019

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: 02/28/2021
• Device Model Number: 33880
• Device Catalogue Number: 33880
• Device Lot Number: 920749
• Distributor Facility Aware Date: 06/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/16/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other