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 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for four patient samples tested with thyroid assays on the cobas 8000 e 801 module and the following analyzers used for investigation: a second e 801 analyzer, a cobas 8000 e 602 module, and a cobas e 411 immunoassay analyzer.Affected tests include elecsys ft3 iii, the elecsys ft4 iii assay, and the elecsys tsh assay.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.Values highlighted in yellow are discrepant.The samples were initially tested on the reporter's e 801 analyzer on (b)(6) 2019.The sample was repeated on a centaur analyzer.The sample was also provided for investigation where it was tested on the e 602 analyzer and e411 analyzer used for investigation on (b)(6) 2019.During investigations, the sample was tested on the second e 801 analyzer on (b)(6) 2019.The e 801 analyzer used by the reporter is serial number (b)(4).The e 602 analyzer used for investigation is serial number (b)(4).Tsh reagent lot number 402248, with an expiration date of 30-nov-2019 was used on this analyzer.The e411 analyzer used for investigation is serial number (b)(4).Tsh reagent lot number 418318, with an expiration date of 29-feb-2020 was used on this analyzer.The e 801 analyzer used for investigation is serial number (b)(4).Tsh reagent lot number 386646, with an expiration date of 31-may-2020 was used on this analyzer.

Manufacturer Narrative

Upon further investigation of sample ids (b)(6), the values generated at the customer site could be reproduced.The investigation could not identify a product problem.The cause of the event could not be determined.The differences in tsh results can be explained by differences caused by different methods, applications, antibodies/antigens, and further differences in standardization and calibrations.

• 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: 9280011
• MDR Text Key: 219331249
• Report Number: 1823260-2019-03975
• 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: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• 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: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1