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 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

This investigation is ongoing.This event occurred in (b)(6).

Event Description

The initial reporter received a questionable elecsys tsh assay result for one patient with the cobas e 801 module serial number (b)(4).Historically, the patient's tsh ran around 1 miu/ml with a normal ft4.Then in (b)(6) 2019, the patient's tsh was 95 miu/ml.A similar result was obtained in (b)(6) 2020.On (b)(6)2020 the initial result was 63.4 miu/ml.The sample was tested with a 1:2 dilution with a result of 64.6 miu/ml.The sample was tested with a 1:5 dilution with a result of 53.4 miu/ml.The sample was tested with precipitation with scantibody tubes and the result was negative and polyethylglycol treatment was negative.Due to scantibody, the customer does not believe the high results are due to macro-tsh.The sample was also processed on a liaison analyzer with a result of 0.65 miu/ml.The questionable result was reported outside the laboratory and questioned by the endocrinologist.

Manufacturer Narrative

The patient sample was provided for investigation.Upon initial investigation, the results obtained by the customer could be reproduced.Further investigations of the sample determined that it contains an interfering factor against the f(ab')2 fragment of the assay antibody as well as the ruthenium label of the assay.Per 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.".

• 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: 11108612
• MDR Text Key: 225291229
• Report Number: 1823260-2021-00008
• 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: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR