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

Catalog Number 07027885190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Sample material was requested for investigation but could not be provided.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter questioned thyroid results for 1 patient tested for elecsys ft3 iii (ft3 iii), elecsys t3 (t3), elecsys t4 (t4) and elecsys anti-tpo (anti-tpo) on a cobas e801 module, a cobas e 411 immunoassay analyzer, a cobas 8000 e 602 module and a cobas 6000 e 601 module compared to the centaur method.This medwatch will cover t4.Refer to medwatch with a1 patient identifier (b)(6) for information on the ft3 iii results, medwatch with a1 patient identifier (b)(6) for information on the t3 results, and medwatch with a1 patient identifier (b)(6) for information on the anti-tpo results.The questionable results were reported outside of the laboratory.The customer suspects an interference affecting the roche results.The centaur results were believed to be correct.Refer to data for the patient results and interference testing performed by the customer.The cobas 8000 system core unit serial number was (b)(4).No other serial numbers were provided.

• Brand Name: ELECSYS T4 ASSAY
• Type of Device: RADIOIMMUNOASSAY, TOTAL 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: 10158860
• MDR Text Key: 199305960
• Report Number: 1823260-2020-01470
• Device Sequence Number: 1
• Product Code: CDX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K961490
• 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: 06/16/2020

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 Expiration Date: 10/31/2020
• Device Catalogue Number: 07027885190
• Device Lot Number: 41543101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/16/2020
• 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
• Patient Age: 75 YR