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

Catalog Number	09005803190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The customer performed calibration approximately once per month.
Event or Problem Description
There was an allegation of questionable elecsys ft3 iii results for 1 patient sample on a cobas e411 module.The initial result was 4.5 pg/ml.The sample was retested, but the result did not change.The customer performed calibration and repeated the sample.The repeated result, after calibration, was 3.6 pg/ml.
Additional Manufacturer Narrative
The calibration was overdue and the slightly higher recovery was also indicated by the rising qc results.A new calibration was performed, which solved the issue.A general product problem can be excluded.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18507429
• Report Number: 1823260-2024-00132
• Device Sequence Number: 18108829
• Product Code: CDP
• UDI-Device Identifier: 07613336171585
• UDI-Public: 07613336171585
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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 Catalogue Number: 09005803190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 02/13/2024
• 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