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

Catalog Number 06437281160

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2024

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 337630974
• Report Number: 1823260-2024-00756
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 04015630934232
• UDI-Public: 04015630934232
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06437281160
• Device Lot Number: 71437201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female