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

Model Number TSH

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

The serial number for the cobas e 801 used at the investigation site was (b)(4).The ft3 iii reagent lot used on this cobas e 801 was 348359 with an expiration date of 31-oct-2019.The serial number for the cobas e 602 used at the investigation site was (b)(4).The tsh reagent lot used on this cobas e 602 was 394647 with an expiration date of 31-oct-2019.The serial number for the cobas e 411 used at the investigation site was (b)(4).The ft3 iii reagent lot used on this cobas e 411 was 347456 with an expiration date of 30-sep-2019.The investigation is ongoing.The event occurred in (b)(6).

Event Description

The initial reporter complained of questionable thyroid results for 1 patient sample tested for ft3 iii assay on a cobas 8000 e 801 module.The patient sample was submitted for investigation.There were discrepant results identified for elecsys ft3 iii between the customer's e 801 module, an e 801 module used at the investigation site, a cobas e 411 immunoassay analyzer used at the investigation site, and the siemens centaur method used at the investigation site.There were discrepant results identified for elecsys tsh assay between the cobas 8000 e 602 module and the siemens centaur method used at the investigation site.This medwatch will cover tsh.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results.It was asked but not known if the questionable results from the customer site were reported outside of the laboratory.Refer to the attachment to the medwatch for all patient data.The e 801 module serial number was (b)(4).

Manufacturer Narrative

A sample was returned for investigation.The customer¿s results were confirmed in the investigation.No interfering factor was found in the sample.The differences of the tsh 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.

• 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: 8916355
• MDR Text Key: 176642787
• Report Number: 1823260-2019-03067
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• 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: 07028091190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1