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

Catalog Number 07976836190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer questioned thyroid results for 2 samples from 1 patient tested on a cobas 6000 e 601 module.Both samples from the patient were submitted for investigation where discrepant results were identified for elecsys ft4 ii assay (ft4 ii), elecsys ft4 iii and elecsys anti-tshr immunoassay (anti-tshr) between the customer's e601 module, a cobas 8000 e 602 module used at the investigation site and the yamasa method.The initial results from the customer site were reported outside of the laboratory.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(6) for information on the ft4 ii erroneous results and medwatch with patient identifier (b)(6) for information on the anti-tshr erroneous results.Refer to attached data for the patient results.There was no allegation that an adverse event occurred.The serial number for the customer's e601 module was (b)(4).The e602 module serial number used at the investigation site was (b)(4).The ft4 iii reagent lot number used at the investigation site was 304692 with an expiration date of jan-2019.Calibration and qc data at the investigation site was acceptable.There was not enough sample material remaining to complete the investigation.Based on the data provided, a general reagent issue can be excluded.The investigation was unable to find 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: 7699326
• MDR Text Key: 114426855
• Report Number: 1823260-2018-02383
• 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: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• 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
• Date Manufacturer Received: 07/05/2018
• 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