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 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter questioned results for 1 patient tested for elecsys pth stat immunoassay (pth stat) and elecsys ft4 iii (ft4 iii) on a cobas 6000 e 601 module.Based on the data provided, the results for ft4 iii, elecsys ft3 iii (ft3 iii) and elecsys tsh (tsh) were discrepant when compared to the abbott method.This medwatch will cover tsh.Refer to medwatch with patient identifier (b)(6) for information on the ft4 iii results, medwatch with patient identifier (b)(6) for information on the pth stat results and medwatch with patient identifier (b)(6) for information on the ft3 iii results.The initial pth stat result from the e601 module was < 0.127 pmol/l with a data flag.On (b)(6) 2019 the repeat result from the e601 module was < 0.127 pmol/l with a data flag.The initial ft3 iii result from the e601 module was 26.58 (unit of measure not provided).On (b)(6) 2019 the sample was repeated by the abbott method with a result of 4.41 pmol/l.The initial tsh result from the e601 module was 0.240 miu/l.On (b)(6) 2019 the sample was repeated by the abbott method with a result of 1.76 uiu/ml on (b)(6) 2019 the initial ft4 iii result from the e601 module was > 100.0 pmol/l with a data flag.On (b)(6) 2019 the repeat result from the abbott method was 14.83 pmol/l.The initial results were reported outside of the laboratory.The customer suspects an interference in the patient sample affecting the results from the roche device.The e601 module serial number was (b)(4).

Manufacturer Narrative

The patient sample was submitted for investigation.The investigation confirmed the presence of an interfering factor to the streptavidin in the reagent.This interference caused the high ft4 iii and ft3 iii results and the low tsh and pth stat results.This specific interference is addressed 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." a product problem was not 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: 9612590
• MDR Text Key: 217655386
• Report Number: 1823260-2020-00174
• 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: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• 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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALENDRONATE.; CALCIUM CARBONATE.; ERGOCALCIFEROL.; LOPERAMIDE.; PANTOPRAZOLE.
• Patient Age: 65 YR