MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 II; RADIOIMMUNOASSAY, FREE THYROXINE

Model Number	FT4 G2
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for 14 patient samples tested with elecsys ft4 ii on cobas e 801 analytical unit serial number (b)(4).All samples initially resulted in ft4 values of > 7.77 ng/dl.The customer provided an example of one patient sample with discrepant ft4 results.The sample initially resulted in an ft4 value of > 7.77 ng/dl with a data flag and this value was reported outside of the laboratory.The physician questioned the result.The sample was repeated, resulting in a value of 0.90 ng/dl.The repeat value was deemed correct.
Additional Manufacturer Narrative
The last calibration performed on 17-mar-2023 was ok and there were no alarms.Quality controls recovered within the customer's specified ranges.Upon review of the alarm trace, a sample clot detection error was observed.This is an indicator of possible poor sample quality.The field service engineer found the reagent pack to be compromised.The reagent pack was removed and samples tested before and after the affected sample were checked; all results were passing.An instrument check, calibration, and controls were run; all were successful.The customer stated that the issue appeared to be isolated to one reagent pack that was near completed.The investigation determined the actions performed by the engineer and customer resolved the issue.

• Brand Name: ELECSYS FT4 II
• Common Device Name: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16732307
• Report Number: 1823260-2023-01248
• Device Sequence Number: 6709543
• Product Code: CEC
• UDI-Device Identifier: 04015630939725
• UDI-Public: 04015630939725
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: FT4 G2
• Device Catalogue Number: 07027397190
• Device Lot Number: 67239201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female