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

Model Number FT4 G3

Device Problem Low Test Results (2458)

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

Event Date 12/16/2021

Event Type  malfunction  

Event Description

There was a complaint of a questionable elecsys ft4 iii assay result for 1 patient tested with cobas e801 module serial number (b)(4).The questionable result was reported outside the laboratory.The result was reported to the physician.The customer repeated the patient¿s sample on a wako accuraseed.A request was made for additional investigation as the e801 generated a low result and the accuraseed fell within the normal reference range.The patient¿s initial result on the e801 was 0.75 ng/dl; the repeat on the accuraseed was 0.98 ng/dl.The patient's sample was submitted for further investigation where discrepant ft4 results were also identified between the customer's e801 module, an e801 module used at the investigation site, and the abbott architect method.Please see the attached data for details.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

The investigation found that a general reagent issue can most likely be excluded.An interfering factor can be excluded.In the case of differences in the values generated with the different analyzers, assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, 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: 13389051
• MDR Text Key: 291733257
• Report Number: 1823260-2022-00233
• 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: 03/01/2022

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
• Device Operator: Health Professional
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 01/28/2022
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 03/01/2022
• 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 Age: 52 YR
• Patient Sex: Female