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 12/28/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).All ft4 results from all types of analyzers were above the upper level of the normal reference range for the respective assays.Calibration and qc at the investigation site were acceptable.From the information provided, a general reagent issue can 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.(b)(6).

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys tsh (tsh) on a cobas e801 module compared to the accuraseed method.The date of event at the customer site is unknown.The date of event is an approximation.The sample was submitted for investigation where discrepant results were identified for tsh, elecsys ft4 iii (ft4 iii) and elecsys ft3 iii (ft3 iii) between the customer's e801 module, an e801 module used at the investigation site, the accuraseed method and the architect method.This medwatch will cover ft4 iii refer to medwatch with patient identifier (b)(6) for information on the tsh results and medwatch with patient identifier (b)(6) for information on the ft3 iii results.Refer to attached data for the patient results.The customer's e801 module serial number was (b)(4).The e801 module used at the investigation site was (b)(4).The ft4 iii reagent lot number used at the investigation site was 432844 with an expiration date of sep-2020.

• 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: 9658827
• MDR Text Key: 199109526
• Report Number: 1823260-2020-00259
• 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: 02/03/2020

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2020
• Initial Date FDA Received: 02/03/2020
• 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: 58 YR