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

Catalog Number 07976836190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer complained of discrepant results for 6 patient samples tested for elecsys ft4 ii assay (ft4 ii) compared to elecsys ft4 iii (ft4 iii) on a cobas 6000 e 601 module.The ft4 ii results were being used for diagnostic purposes.It is not known if the ft4 ii results were reported outside of the laboratory.The ft4 iii results were being used during validation of the new assay.It is not clear which results were believed to be correct.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(6) for information on the ft4 ii results.Refer to attached data for the patient results.The initial ft4 ii results for all patient samples are far above the normal reference range of the assay.The patient results from the ft4 iii assay were either within the normal reference range of the assay or just above it.There was no allegation that an adverse event occurred.The e601 module serial number was (b)(4).Based on the data provided a general reagent issue can be excluded.Since no sample material can be provided, the investigation could not be completed.The investigation was unable to determine a definitive root cause.

• 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: 7825995
• MDR Text Key: 118535394
• Report Number: 1823260-2018-02908
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 07613336153956
• UDI-Public: 7613336153956
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 08/29/2018

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 Catalogue Number: 07976836190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 08/29/2018
• 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