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

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer complained of high results for 1 patient sample tested for elecsys ft4 ii assay (ft4 ii) and elecsys ft3 iii (ft3 iii) on a cobas 6000 e 601 module.The initial ft3 iii and ft4 ii results were reported outside of the laboratory where the physician complained that the results did not correspond to the patient's clinical picture.The sample was sent for testing by the abbott method along with repeat testing with an edta plasma sample on the customer's e601 module and repeat testing on another hospitals e601 module.Based on the data provided, discrepant results were identified for ft4 ii, ft3 iii, elecsys t3 (t3) and elecsys t4 assay (t4).Refer to medwatches with the following patient identifiers for the assays involved: (b)(6).There was no allegation that an adverse event occurred.The customer's e601 serial number was (b)(4).The e601 serial number used at the external laboratory was not provided.

Manufacturer Narrative

Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed.This caused the high ft4 ii, ft3 iii, t3 and t4 results.This interference is covered in product labeling.Product labeling states "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.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.".

• 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: 7300026
• MDR Text Key: 101509598
• Report Number: 1823260-2018-00587
• Device Sequence Number: 1
• Product Code: CDX
• Combination Product (y/n): N
• PMA/PMN Number: K961490
• 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: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• 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: 02/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1