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 07/03/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation could not identify a product problem.A general reagent issue can be excluded.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 differences in the standardization methodology used.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys ft4 iii assay on two cobas 8000 e 801 modules.The result measured at the customer site was reported outside of the laboratory to a physician.The sample initially resulted in a ft4 value of 1.82 ng/dl (reference range = 0.90 - 1.70 ng/dl) when tested on the customer's e 801 analyzer.The sample was repeated on an abbott architect analyzer, resulting in a value of 1.31 ng/dl (reference range = 0.7 - 1.48 ng/dl).The sample was also provided for investigation, where it was tested on a second e 801 analyzer on (b)(6) 2021, resulting in a value of 1.76 ng/dl.The serial number of the customer's e 801 analyzer was (b)(4).Ft4 reagent lot 520701, with an expiration date of 31-jan-2022 was used on this analyzer.The serial number of the e 801 analyzer used for investigation was (b)(4).Ft4 reagent lot 520701, with an expiration date of 31-jan-2022 was used on this analyzer.

• 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: 12270768
• MDR Text Key: 268330481
• Report Number: 1823260-2021-02274
• 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,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2021

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 Expiration Date: 01/31/2022
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976887190
• Device Lot Number: 520701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/03/2021
• 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