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

Model Number FT4 G3

Device Problem High Test Results (2457)

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

Event Date 11/30/2021

Event Type  malfunction  

Manufacturer Narrative

Upon investigation of submitted data, a general reagent problem can be excluded because the provided qc data were within specifications.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received a questionable elecsys ft4 iii assay result for one patient sample tested on the cobas e 801 analytical unit with serial number (b)(4).The initial result was not reported outside of the laboratory.The initial sample was rerun on the same instrument.It was also sent out to a laboratory which uses an abbott analyzer.The patient's treatment plan includes a plan for thyroid resistance if the roche result correlated with the abbott analyzer's result.A new sample was also obtained from the patient.On (b)(6) 2021 at 12:43 pm, the initial result was 2.020 ng/dl.The repeat result from the analyzer at an unknown time was 2.05 ng/dl.At 1:39 pm, the result from the new patient sample was 1.940 ng/dl.On (b)(6) 2021 at 4:24 pm, the repeat result from the abbott analyzer was 1.25 ng/dl.

• Brand Name: ELECSYS FT4 III 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13117302
• MDR Text Key: 290278432
• Report Number: 1823260-2021-03924
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976887190
• Device Lot Number: 541093
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Sex: Male