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

Model Number	TSH
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For one event, the sample was returned for investigation.The customer's roche results were reproduced.Interference testing was performed and no interfering factors were identified.The investigation did not identify a product problem.The cause of the event could not be determined.The follow up actions for this event were: the sample was requested for investigation.For four events, the investigation could not identify a product problem.The cause of the events could not be determined.There were no follow up actions for these events.For two of the events, the investigations are currently ongoing.For one event, the investigation is currently ongoing.The follow up actions for this event were: sample from the patient was submitted for investigation.For one event, the investigation did not identify a product problem.The cause of the event could not be determined.Results from different manufacturer's are known to be different due to the different types of antibodies used, differences in setups of the assays, and differences in standardization methodologies.The device was not returned for investigation.This device is not labeled for single use and is not reprocessed or reused.Lot numbers cont'd: 418318, 386646, 40817601, asku.
Event or Problem Description
This report summarizes 9 malfunction events.Questionable high elecsys tsh results were generated by 5 cobas 6000 e 601 module analyzers, 4 cobas 8000 e 602 module analyzers, 1 cobas e 411 immunoassay analyzer, and 2 cobas e 801 module analyzers.The events involved ten patient samples.Four patients' ages ranged between 20 and 70 years old.The remaining patients' ages were requested, but not provided.The patients' weights were requested, but not provided.There were three males and two females.The remaining patients' genders were requested, but not provided.The patients' races were requested, but not provided.The patients' ethnicities were requested, but not provided.
Additional Manufacturer Narrative
For one pending event: the investigation could not identify a product problem.The cause of the event could not be determined.The patient sample was provided for investigation and the values measured by the customer could be reproduced.No interfering factors to the tsh assay were detected in the sample.For one pending event: the investigation could not identify a product problem.The cause of the event could not be determined.No interfering factors to the tsh assay were detected in the sample.For one pending event: for one event, the investigation could not identify a product problem.The cause of the event could not be determined.The patient sample could not be provided for investigation.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 46250
• MDR Report Key: 9641133
• Report Number: 1823260-2020-90037
• Device Sequence Number: 16695461
• Product Code: JLW
• UDI-Device Identifier: 04015630899661
• UDI-Public: 04015630899661
• Combination Product (Y/N): N
• Number of Events Summarized: 9
• 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 Catalogue Number: 11731459122
• Device Lot Number: 402248, 41831803,
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 04/16/2020
• Patient Sequence Number: 1