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

Model Number	TSH
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis, in
• MDR Report Key: 10331868
• Report Number: 1823260-2020-90112
• Device Sequence Number: 972503
• Product Code: JLW
• UDI-Device Identifier: 04015630899661
• UDI-Public: 04015630899661
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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?: No
• Operator of Device: No Information
• Device Model Number: TSH
• Device Catalogue Number: 11731459122
• Device Lot Number: ASKU
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 10/22/2020
• Patient Sequence Number: 1