MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH ASSAY; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number TSH

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently ongoing.The event occurred in: (b)(6).

Event Description

The initial reporter complained of questionable thyroid results for one patient tested on a cobas 8000 e 801 module.The patient had questionable elecsys tsh assay, elecsys ft3 iii, and elecsys ft4 iii assay results compared to the results from an abbott system.The customer suspects that maybe there is an interference issue affecting the results.This medwatch will cover tsh.For information on ft4 iii refer to the medwatch with patient identifier (b)(6).For information on ft3 iii refer to the medwatch with patient identifier (b)(6).The cobas e801 results were: tsh 3.5 mu/l, ft4 iii 30.3 pmol/l, ft3 iii 7.96 pmol/l.The results from the abbott system were: tsh 2.0 mu/l (reference range 0.7 - 4.2 mu/l), ft4 17.94 pmol/l (reference range 11.48 - 17.67 pmol/l), ft3 6.76 pmol/l (reference range 4.3 - 6.81 pmol/l).The cobas e801 serial number was (b)(4).

Manufacturer Narrative

One sample was returned for investigation.The customer¿s results were confirmed.An interfering factor could not be identified in the sample.A general reagent issue can be excluded.The mathematical differences of the tsh and ft4 and ft3 values, generated with the different types of analyzers, are caused by differences of the setups of the assays, the antibodies used and differences of the standardization materials and procedures used.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TSH ASSAY
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8831473
• MDR Text Key: 152681625
• Report Number: 1823260-2019-02727
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• PMA/PMN Number: K961491
• 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: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TSH
• Device Catalogue Number: 08443432190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 YR