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 08/18/2018

Event Type  malfunction  

Manufacturer Narrative

The event occurred in: (b)(6).(b)(6).

Event Description

The customer complained of questionable results for multiple tests for multiple patients.From the data provided a reportable malfunction was provided for the following number of patients for the following tests: 4 patients for elecsys tsh assay, 7 patients for elecsys t3, 5 patients for elecsys t4 assay, 2 patients for elecsys ft4 ii assay, 1 patient for roche diagnostics cobas elecsys anti-tpo, and 1 patient for elecsys estradiol ii assay (e2).The customer performed their testing on a cobas 8000 e 801 module and a cobas 6000 e 601 module.The results were compared to an outside laboratories cobas e801, cobas e601, a roche diagnostics elecsys e170 modular analytics immunoassay analyzer, and a siemens centaur.This medwatch will cover t4.Please refer to the following medwatches with the following patient identifiers.(b)(6) for tsh; (b)(6) for t3; (b)(6) for ft4; (b)(6) for anti-tpo; (b)(6) for e2.Refer to the attachment for patient data.The discrepant results are highlighted.The patient information that was provided is included in the attachment.It was unknown if the erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The customer's cobas e801 serial number was (b)(4).The customer's cobas e601 serial number information was not provided.The investigation is currently ongoing.

Manufacturer Narrative

For the discrepant t4 results, a sample of patients 1, 3, 4, 5, and 7 was provided for further investigation.The investigation determined that an interfering factor against a component of the reagent could be identified.This type of interfering factor is addressed in product labeling.The difference generated between the cobas e601 and cobas e801 modules are most likely caused by small differences in the overall physical reaction conditions of the different types of analyzers.The investigation did not identify a product problem.

• 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: 8103535
• MDR Text Key: 128397332
• Report Number: 1823260-2018-04468
• 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: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 07027885190
• Device Lot Number: 28709300
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR