MAUDE Adverse Event Report: BECKMAN COULTER ACCESS FREE T3 REAGENT; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Model Number	ACCESS FREE T3 REAGENT
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Full patient identifier is case-(b)(6).The customer did not provide patient demographics such as date of birth, weight, ethnicity or race.The access free t3 reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.Samples were sent to the complaint handling unit for interference testing.Interference testing including polymak 33 and hbr-1, goat and sheep igg, and scavenger alp (alkaline phosphatase) and ap mutein with blockers related to alkaline phosphatase were used.The interference testing did not indicate presence of any of these interferents in the patient sample.There is evidence of discordance as the patient's access free t3 results were discordant to two competitor platforms and the patient clinical profile.(b)(6).In conclusion, the cause of this event cannot be determined with the available information.Customer telephone number: (b)(6).
Event or Problem Description
On (b)(6) 2020 the customer reported erroneous reproducible elevated free t3 (access free t3, part number a13422 and lot number 921603) of 12.1 pg/ml was generated for one patient on the laboratory's dxi 800 access immunoassay analyzer (part number a71456 and serial number(b)(4)) on (b)(6) 2020.The patient was diagnosed as hyperthyroid.On (b)(6) 2020 the patient was redrawn and a free t3 result of 9.48 pg/ml was obtained.There was a report of change to patient treatment associated with the elevated free t3 result.The patient was administered ptu (propythiouracil), mmi (methimazole) and lugol (dosages and dose intervals not provided).There was no further report of change to patient treatment associated with the elevated free t3 result and there were no further adverse patient outcomes reported.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.There were no reports of hardware errors or issues with other assays reported in conjunction with this event.No other patient results were called into question.There were no issues reported with sample integrity.The patient was redrawn on (b)(6) 2020.Elevated free t3 results were again obtained.Samples from (b)(6) 2020 and (b)(6) 2020 were also tested on competitor platforms; results of testing on competitor platforms were concordant with the patient's clinical profile.The access free t3 results were discordant to the clinical profile and the competitor results.Interference was suspected and additional samples were sent to the complaint handling unit for interference testing.

• Brand Name: ACCESS FREE T3 REAGENT
• Common Device Name: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 10637943
• Report Number: 2122870-2020-00084
• Device Sequence Number: 11388800
• Product Code: CDP
• UDI-Device Identifier: 15099590201661
• UDI-Public: (01)15099590201661(17)210131(11)200201(10)921603
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: ACCESS FREE T3 REAGENT
• Device Catalogue Number: A13422
• Device Lot Number: 921603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR