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

Model Number	TSH
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the first and second event, the investigation did not identify a product problem.The cause of the event could not be determined.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials, and differences in the standardization methodology used.For the third and fourth event, the investigation is ongoing.There were no follow up/corrective actions.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 4 malfunction event.Erroneous low results for the tsh elecsys cobas e 200 assay.The events involved a total of four patients.Two of the patients' ages ranged from 14 to 84 years.There was 1 female and 1 male.
Additional Manufacturer Narrative
For one of the pending events, the investigation determined that for tsh that the mathematical differences of the tsh values, generated with the analyzers from roche diagnostics and siemens, are caused by differences of the setups of the assays, the antibodies used and differences of the standardization materials and procedures used.There were no follow up activities.For the other pending event, the investigation determined sample from the patient contained an interfering factor to a component of the reagent.This interference is documented in product labeling for the assay.

• Brand Name: ELECSYS TSH ASSAY
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8830158
• Report Number: 1823260-2019-90178
• Device Sequence Number: 2743083
• Product Code: JLW
• UDI-Device Identifier: 04015630899661
• UDI-Public: 04015630899661
• Combination Product (Y/N): N
• Number of Events Summarized: 4
• Summary Report (Y/N): Y
• 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 Lot Number: ASKU
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 10/22/2019
• Patient Sequence Number: 1