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 one event, 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 underwent preliminary investigation, however, there was no sample material remaining for further investigation.For one event, the investigation did not identify a product problem.The cause of the event could not be determined.There were no follow up actions for this event.For three of the events, the investigations are currently ongoing.The device was not returned for investigation.This device is not labeled for single use and is not reprocessed or reused.
Event or Problem Description
This report summarizes 5 malfunction events.Questionable low elecsys tsh results were generated by 3 cobas 6000 e 601 module analyzers and three cobas 8000 e 602 module analyzers.The events involved six patient samples.2 patients were ages between 3 and 83 years old.The remaining patients' ages were requested, but not provided.The patients' weights were requested, but were not provided.There were two males and one female.The remaining patients' genders were requested, but not provided.The patients' races were requested, but were not provided.The patients' ethnicities were requested, but were not provided.

• Brand Name: ELECSYS TSH ASSAY
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; mannheim (baden-wurttemberg), 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 9641139
• Report Number: 1823260-2020-90036
• Device Sequence Number: 2204589
• Product Code: JLW
• UDI-Device Identifier: 04015630899661
• UDI-Public: 04015630899661
• Combination Product (Y/N): N
• Number of Events Summarized: 5
• 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
• Device Model Number: TSH
• Device Catalogue Number: 11731459122
• Device Lot Number: 418318, ASKU, 404125
• Type of Report(Section G): Initial
• 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: 01/30/2020
• Patient Sequence Number: 1
• Patient Sex: Unknown