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 Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter questioned results for 1 patient sample tested for elecsys ft4 iii (ft4 iii), elecsys tsh (tsh) and elecsys ft3 iii (ft3 iii) on a cobas e801 module compared to the accuraseed instrument.The sample was submitted for investigation where discrepant results were identified for ft4 iii and ft3 iii between the customer's e801 module, the architect method and an e801 module used at the investigation site.The initial results from the customer site had been reported outside of the laboratory.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results.There was no allegation that an adverse event occurred.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 380330 with an expiration date of dec-2019.Calibration and qc data at the investigation site was acceptable.Based on the data provided, a general reagent issue can be excluded.All ft4 iii and ft3 iii results were within the normal reference range for the respective assay.Assays from different manufacturers, in this case architect, can generate different results.This relates to the overall setup of each assay, the antibodies used and differences in reference materials and standardization methodology.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 8581985
• MDR Text Key: 144555466
• Report Number: 1823260-2019-01682
• 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: 05/06/2019

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: 04/15/2019
• Initial Date FDA Received: 05/06/2019
• 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