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

Catalog Number	07027362190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The customer suspects an interfering factor in the patient's samples.The sample has been requested for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys ft3 iii and elecsys ft4 iii assay results for 2 patient samples on a cobas e 801 analytical unit compared to a siemens analyzer and an abbott architect analyzer.The customer also states that the roche results do not match the patient's clinical picture.Refer to the attachment to the medwatch for all patient data.This medwatch will cover ft3 iii.Refer to medwatch with a1 patient identifier pt-00067637 for information on the ft4 iii results.
Additional Manufacturer Narrative
The patient sample was received for investigation.The investigation was able to confirm the customer's ft3 and ft4 results.No assay interfering factors were identified in the patient sample.The investigation did not identify a product problem.

• Brand Name: ELECSYS FT3 III
• Common Device Name: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18932052
• Report Number: 1823260-2024-00807
• Device Sequence Number: 9291237
• Product Code: CDP
• UDI-Device Identifier: 04015630939718
• UDI-Public: 04015630939718
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K963127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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: 10/31/2024
• Device Catalogue Number: 07027362190
• Device Lot Number: 74047401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown