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 01/04/2022

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The initial reporter questioned results for 1 patient sample tested for elecsys tsh (tsh) and elecsys ft4 iii assay on a cobas e801 module.The initial results from the customer site were reported outside of the laboratory.The sample was submitted for investigation where discrepant results were identified for tsh and ft4 iii between the customer¿s e801 module, an e 801 module at the investigation site and the abbott architect method.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(6) for information on the tsh results.The customer¿s e801 module serial number was not provided.The e801 module serial number used at the investigation site was (b)(4).The ft4 iii reagent lot with expiration date used at the customer site was not provided.The ft4 iii reagent lot number used at the investigation site was 541093 with an expiration date of 31-may-2022.

Manufacturer Narrative

The ft4 iii reagent lot used at the customer site was 541093 with an expiration date of 31-may-2022.Based on the information provided, a general reagent issue can be excluded.An interfering factor can also be excluded.Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials and the standardization methodology used.The investigation did not identify a product problem.

• 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: 13523096
• MDR Text Key: 292189099
• Report Number: 1823260-2022-00363
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• 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: ASKU, 54109302
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• 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 Sex: Female