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 Consequences Or Impact To Patient (2199)

Event Date 12/24/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.Results with the different analyzers from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used.From the information provided, a general reagent issue can most likely be excluded.This event occurred in (b)(6)- attachment: (b)(4).

Event Description

The initial reporter received questionable elecsys ft4 iii assay results for one patient from cobas e 801 module serial number (b)(4).The sample was submitted for investigation and was tested on architect analyzer and a cobas e 801 module.Refer to the attachment to the medwatch for all patient data.This medwatch is for ft4.Refer to the medwatch with patient identifier (b)(4) for the tsh assay and (b)(4) for the ft3 assay.The customer reported out the results to a physician.

• 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: 9641397
• MDR Text Key: 220041620
• Report Number: 1823260-2020-00229
• 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: 01/29/2020

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: 43284400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 01/29/2020
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR