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 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

The serial number for the cobas e 801 used at the investigation site was (b)(4).The tsh reagent lot used on this cobas e 801 was 386646 with an expiration date of 31-may-2020.The ft4 iii reagent lot used on this cobas e 801 was 380330 with an expiration date of 31-dec-2019.The ft3 iii reagent lot used on this cobas e 801 was 348359 with an expiration date of 31-oct-2019.The investigation is ongoing.This event occurred in (b)(6).

Event Description

The initial reporter complained of questionable elecsys tsh assay, elecsys ft4 iii assay, and elecsys ft3 iii results for 1 patient sample on a cobas 8000 e 801 module compared to the wako accursed method.The patient sample was submitted for investigation where discrepant results were identified for tsh, ft4 iii, and ft3 iii an e801 module used at the investigation site and the wako accuraseed method.The discrepant results from the customer site were reported outside of the laboratory.This medwatch will cover tsh.Refer to medwatch with patient identifier.Patient identifier (b)(6) for information on the ft4iii results and medwatch with patient identifier.Patient identifier (b)(6) for information on the ft3 iii results.The customer's cobas e 801 serial number was not provided.

Manufacturer Narrative

A sample was provided for investigation.An interfering factor was identified.This interference is addressed in the package insert: 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.No product problem could be found.

• 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: 8975711
• MDR Text Key: 203820027
• Report Number: 1823260-2019-03229
• 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: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• 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: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1