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

Catalog Number 07976887190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The customer questioned thyroid results for 6 patient samples tested for elecsys ft3 iii (ft3 iii), elecsys tsh (tsh) and elecsys ft4 iii (ft4 iii) on a cobas e 801 module.The 6 patient samples were submitted for investigation where discrepant results were identified for ft3 iii, tsh and ft4 iii between the customer's e801 module, the centaur method, an e801 module used at the investigation site, a cobas 8000 e 602 module used at the investigation site and a cobas e 411 immunoassay analyzer used at the investigation site.It is not known if any incorrect results were reported outside of the laboratory.This medwatch will cover ft4 iii.Refer to medwatch with (b)(6) for information on the tsh erroneous results and medwatch with (b)(6) for information on the ft3 iii erroneous results.Refer to attached data titled "patient results" for the patient results.There was no allegation that an adverse event occurred.The serial number for the customer's e801 module was not provided.The patient samples were also treated and underwent polyethylene glycol (peg) testing.Refer to attached data titled "peg testing" for these results.The e602 module serial (b)(4).The e411 analyzer serial (b)(4).The e801 module serial number used at the investigation site was (b)(4).The ft4 iii reagent lot number used with the e602 module and the e411 analyzer was 304692 with an expiration date of 31-jan-2019.The ft4 iii reagent lot number used with the e801 module at the investigation site was 304694 with an expiration date of 31-jan-2019.There was not enough sample volume left to complete the investigation.Based on the data provided, a general reagent issue can be excluded.Assays from different manufacturers can generate different results.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: 7719580
• MDR Text Key: 115368070
• Report Number: 1823260-2018-02464
• 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: 07/25/2018

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: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 07/25/2018
• 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