MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T4 ASSAY; RADIOIMMUNOASSAY, TOTAL THYROXINE

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of discrepant results for 1 patient sample tested for elecsys t4 (t4) and elecsys t3 (t3) on a cobas e801 module and a cobas 6000 e 601 module compared to the abbott method.This medwatch will cover t4 on the e601 module.Refer to medwatch with patient identifier (b)(6) for information on the t4 results on the e801 module, medwatch with patient identifier (b)(6) for information on the t3 results on the e801 module and medwatch with patient identifier (b)(6) for information on the t3 results on the e601 module.The erroneous results were not reported outside of the laboratory.There was no allegation that an adverse event occurred.The e801 module serial number was (b)(4).The e601 module serial number was not provided.

Manufacturer Narrative

Upon further investigation of the patient sample, an interferent against the streptavidin component of the reagent was confirmed.This interference is covered in product labeling: "in rare cases, interference due to extremely high titers of antibodies to analyte specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.".

• Brand Name: ELECSYS T4 ASSAY
• Type of Device: RADIOIMMUNOASSAY, TOTAL THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8357575
• MDR Text Key: 136740066
• Report Number: 1823260-2019-00719
• Device Sequence Number: 1
• Product Code: CDX
• Combination Product (y/n): N
• PMA/PMN Number: ASKU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATIENT DOES NOT TAKE MEDICATION; PATIENT DOES NOT TAKE MEDICATION
• Patient Age: 67 YR