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

Catalog Number	06437281160
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer alleged discrepant results for two patient samples tested with the elecsys ft4 ii assay on the cobas 8000 e 602 module.Sample 1 resulted in a ft4 value of 2.15 ng/dl when tested on the e 602 module.The result was higher than expected and was repeated on the same e 602 module, resulting in a ft4 value of 1.17 ng/dl.Sample 2 resulted in a ft4 value of 2.45 ng/dl when tested on the e 602 module.The result was higher than expected and was repeated on the same e 602 module, resulting in a ft4 value of 1.52 ng/dl.The repeat results were deemed correct.
Additional Manufacturer Narrative
The serial number of the cobas e 602 module is (b)(6).Due to repeated calibration failures, the customer replaced the reagent pack, calibrated, and ran qc which was acceptable.The field service engineer (fes) confirmed there was an issue with the specific reagent pack the customer had replaced.The fes performed checks and verified the instrument by having the customer perform calibration, qc, and performing patient correlations successfully.The investigation determined the replacement of the reagent pack resolved the issue.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18902016
• Report Number: 1823260-2024-00756
• Device Sequence Number: 9068953
• Product Code: CEC
• UDI-Device Identifier: 04015630934232
• UDI-Public: 04015630934232
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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
• Report Date (Section B): 03/14/2024

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: 08/31/2024
• Device Catalogue Number: 06437281160
• Device Lot Number: 71437201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/14/2024
• 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: Female