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 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The patient's samples were requested and submitted for an investigation.The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys tsh assay results for one patient tested on a cobas 8000 e 801 module.The serial number of the e 801 module was requested but not provided.The patient had two samples collected, on (b)(6) 2020 and (b)(6) 2020.The patient's tsh results were reported outside the laboratory and the physician did not believe the results.The customer performed further testing with the patient's samples on a siemens analyzer and a beckman coulter dsi analyzer.

Manufacturer Narrative

On (b)(6) 2020, the customer reported the patient had a new sample collected.The patient's results were tsh 26 uiu/ml with a data flag, ft4 0.94 ng/dl, and ft3 2.91 pg/ml.Also, the customer reported "during the last weeks no further thyroxin was taken by patient." the customer's calibration and qc data were requested but not provided.The investigation reproduced the customer's tsh results.Upon further investigation of the patient samples, an interferent against a component of the reagent was confirmed, ru-label.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 investigation did not identify a product problem.

• 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: 10778755
• MDR Text Key: 214394657
• Report Number: 1823260-2020-02756
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: TSH
• Device Catalogue Number: 08443432190
• Device Lot Number: 47973901
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: L-THYROXINE; L-THYROXINE
• Patient Age: 45 YR