MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH ASSAY; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number TSH

Device Problem Non Reproducible Results (4029)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event.Erroneous non-reproducible results were generated for one patient sample tested with the elecsys tsh assay on a cobas 8000 e 602 module and a cobas 6000 e 601 module.The patient's age was requested, but were not provided.The patient's weight was requested, but was not provided.The patient's gender was requested, but was not provided.The patients' races was requested, but was not provided.The patients' ethnicities was requested, but was not provided.

Manufacturer Narrative

For the one event, a second sample from the same patient also had discrepant results for the elecsys tsh assay on a cobas 8000 e 602 module and a cobas 6000 e 601 module.For this event, a sample from the patient was provided for investigation and the investigation determined the sample contains a factor that interferes with the streptavidin component of the tsh 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." there were no follow up actions for this event.

• Brand Name: ELECSYS TSH ASSAY
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis, in
• MDR Report Key: 10331868
• MDR Text Key: 202770893
• Report Number: 1823260-2020-90112
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 04015630899661
• UDI-Public: 04015630899661
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: TSH
• Device Catalogue Number: 11731459122
• Device Lot Number: ASKU
• Patient Sequence Number: 1