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

Model Number FT4 G3

Device Problem High Test Results (2457)

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

Event Date 04/12/2022

Event Type  malfunction  

Event Description

The initial reporter received questionable elecsys tsh assay and elecsys ft4 iii assay results for 4 patients whose samples were tested on a cobas 8000 e801 module with serial number (b)(4).It is unknown if the initial results were reported outside of the laboratory.The patient samples were sent to an investigation site and an outsourced laboratory.The investigation site uses a cobas e 801 and a cobas e 411.The outsourced laboratory uses an abbott architect analyzer.Please refer to the attachment in the medwatch for the questionable results.The serial number of the e 801 at the investigation site is (b)(6).The serial number of the e 411 at the investigation site is (b)(6).This medwatch is for the ft4 iii assay.Refer to the medwatch with a1 patient identifier pt-(b)(6) for the tsh v2 assay.

Manufacturer Narrative

For the differences in the tsh and ft4 values generated from the different analyzers, it needs to be taken into account that 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.In case a sample is analyzed with different analyzers, the generated values are to be interpreted in relation to the normal reference ranges of the assays of the different analyzers.The investigation did not identify a product problem.

• Brand Name: ELECSYS FT4 III
• 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: 14468667
• MDR Text Key: 300394073
• Report Number: 1823260-2022-01459
• 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
• Report Date: 05/23/2022

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: 07976836190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 05/23/2022
• 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