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

Model Number	FT4 G2
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qc was acceptable on the day of the event.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys ft4 ii assay results for 1 patient sample on a cobas e 801 analytical unit.The initial plasma tube ft4 result was 0.77 ng/dl.The repeat result was 0.93 ng/dl.The initial result was reported outside of the laboratory.The repeat result was deemed correct.The analyzer serial number is (b)(4).
Additional Manufacturer Narrative
It was found that the customer was using single-use calibrator material more than once and was also not cleaning the sipper flow path as outlined in the operator's manual.The root cause of the event was found to be the customer's improper product handling.

• 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: 16707419
• Report Number: 1823260-2023-01170
• Device Sequence Number: 5772638
• 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): N
• 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): 06/05/2023

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: 07/31/2023
• Device Model Number: FT4 G2
• Device Catalogue Number: 07027397190
• Device Lot Number: 62615001
• 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: 03/14/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 06/05/2023
• 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: 31 YR
• Patient Sex: Male