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 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The initial reporter questioned thyroid results for 1 patient sample tested on a cobas 8000 e 801 module compared to an accuraseed analyzer.Based on the data provided, the elecsys tsh assay, elecsys ft4 iii assay, and elecsys ft3 iii results were discrepant between the accuraseed analyzer and the customer's e 801 module.The customer questioned the anti-tshr results from the yamasa method.The sample was submitted for investigation where discrepant elecsys anti-tshr immunoassay results were identified between the yamasa method and an e801 module used at the investigation site.This medwatch will cover tsh.Refer to medwatch with patient identifier (b)(6) for information on the ft4iii results, medwatch with patient identifier (b)(6) for information on the ft3 iii results, and medwatch with patient identifier (b)(6) for information on the anti-tshr results.The initial results from the e 801 module were reported outside of the laboratory.There was no allegation that an adverse event occurred.The customer's e 801 module serial number was (b)(4).

Manufacturer Narrative

Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed.This interference is covered in product labeling.Product labeling states "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: 8776892
• MDR Text Key: 150756009
• Report Number: 1823260-2019-02501
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• 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: 06/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1