MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 II ASSAY; 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	04/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable elecsys ft4 ii result from one patient sample tested on the cobas 6000 e 601 module with serial number (b)(6).The reporter stated that two physicians requested the same assay for the patient.Two sample tubes were then collected from a single blood draw.The reporter stated that the patient samples were run almost at the same time.The result of the first sample tube was 0.1 ng/dl.The result of the second sample tube was 1.1 ng/dl.This result was deemed correct.The results from both sample tubes were reported outside of the laboratory.
Additional Manufacturer Narrative
H3: na.
Additional Manufacturer Narrative
It was found that the customer centrifuges their specimens for 5 minutes at 5600 rpm, which may be too short and too fast.The field service engineer (fse) verified all mixer positions, straightened a slightly bent nozzle, cleaned a line, and performed a 21-cup precision check successfully.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: ELECSYS FT4 II ASSAY
• 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: 16932077
• Report Number: 1823260-2023-01635
• Device Sequence Number: 6841344
• Product Code: CEC
• UDI-Device Identifier: 04015630934232
• UDI-Public: 04015630934232
• 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): 07/03/2023

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 Model Number: FT4 G2
• Device Catalogue Number: 06437281160
• Device Lot Number: ASKU
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 07/03/2023
• 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: 35 YR
• Patient Sex: Female