MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT3 III; TOTAL TRIIODOTHYRONINE

Model Number	FT3 III
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e601 analyzer was with a serial number of (b)(6).Qc was last performed on 24-may-2023.The analyzer had reagent errors on the day of the event and the qc couldn't be performed.The provided alarm trace contained several alarms including sample short alarms.The field service engineer (fse) found that salt was built up on the nozzle and the assembly which were cleaned and reseated.The customer performed calibration and qc and they were acceptable.The customer then ran a patient sample and the result matched the result from the other analyzer.The investigation determined that the fse service actions solved the issue.H3 other text : na.
Event or Problem Description
We received an allegation about discrepant results for 1 patient's plasma sample tested with elecsys ft3 g3 (ft3 iii) assay on a cobas e601 immunoassay analyzer when compared to another cobas e601 immunoassay analyzer.The customer reported a >25 pg/ml which was accompanied by a data flag >test.The customer did not realize that the instrument needed to dilute the sample and the diluted value was 7.5 pg/ml.The repeat result was 2.5 pg/ml (on a different e601) which was deemed correct.The laboratory is in the process of correcting the report.

• Brand Name: ELECSYS FT3 III
• Common Device Name: TOTAL TRIIODOTHYRONINE
• 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: 17177472
• Report Number: 1823260-2023-02043
• Device Sequence Number: 6809419
• Product Code: CDP
• UDI-Device Identifier: 07613336171585
• UDI-Public: 07613336171585
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 06/21/2023

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: 05/30/2023
• Device Model Number: FT3 III
• Device Catalogue Number: 09005803190
• Device Lot Number: 611918
• 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: 05/25/2023
• Initial Report FDA Received Date: 06/21/2023
• 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 Sex: Male