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
The investigations could not identify a product problem for five of the events.The cause of these events could not be determined.There were no follow up/corrective actions for these events.The investigations for two of the events are currently 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 7 malfunction events.Erroneous low results were generated by 4 cobas 8000 e 602 modules, a cobas e 411 immunoassay analyzer, a cobas e 801 module, and an elecsys e170 modular analytics immunoassay analyzer.The events involved a total of 7 patients with the following: seven erroneous results with the elecsys tsh assay.Two patients' ages ranged from 9 days to 39 years.There were 2 females.
Additional Manufacturer Narrative
For the two remaining 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.For one of the events where it was previously reported that the investigation did not identify a product problem, sample from the patient was submitted for investigation.The biotin concentration was found to be far above the allowable threshold concentration specified in product labeling for the assays.This high biotin concentration most likely caused event.There was no malfunction of the device.

• 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: 8549720
• Report Number: 1823260-2019-90123
• Device Sequence Number: 2309063
• Product Code: JLW
• UDI-Device Identifier: 04015630899661
• UDI-Public: 04015630899661
• Combination Product (Y/N): N
• Number of Events Summarized: 7
• 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

• Operator of Device: No Information
• Device Model Number: TSH
• Device Lot Number: ASKU, 349487, 365417
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 07/22/2019
• Patient Sequence Number: 1