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 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that they received discrepant results for two patient samples tested with elecsys ft3 iii, elecsys ft4 iii assay, and the elecsys tsh assay on a cobas 8000 e 801 module and a cobas e 411 immunoassay analyzer, cobas 8000 e 602 module, and second e 801 analyzer used for investigation.It was asked, but it is not known if any incorrect results were reported outside of the laboratory.This medwatch will apply to the tsh assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay and refer to the medwatch with patient identifier (b)(6) for information related to the ft4 assay.The samples were initially tested on the reporter's e 801 analyzer on (b)(6) 2019.The samples were repeated on a centaur analyzer.The samples were also provided for investigation, where they were tested on an e 602 analyzer and a second e 801 analyzer on (b)(6) 2019.For investigation, the samples were also tested on an e411 analyzer on (b)(6) 2019.The serial number of the e 602 analyzer used for investigation is (b)(4).Tsh reagent lot number 394674, with an expiration date of 31-oct-2019 was used on this analyzer.The serial number of the e411 analyzer used for investigation is (b)(4).Tsh reagent lot number 394674, with an expiration date of 31-oct-2019 was used on this analyzer.The serial number of the e 801 analyzer used for investigation is (b)(4).Tsh reagent lot number 386646, with an expiration date of 31-may-2020 was used on this analyzer.

Manufacturer Narrative

Upon investigation of the patient sample, an interferent against a component of the reagent was confirmed.This interference is covered in product labeling: 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.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: 8884720
• MDR Text Key: 154032931
• Report Number: 1823260-2019-02952
• 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: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• 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: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1