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 investigations could not identify a product problem for four of the events.The cause of these events could not be determined.No follow up/corrective actions were taken for three of these four events.The follow up/corrective action for one of these four events was: calibration and qc were tested and acceptable.The investigations for three of the events are currently ongoing.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.Lot #: asku, serial #s: (b)(4).
Event or Problem Description
This report summarizes 7 malfunction events.Erroneous non-reproducible results were generated by 3 cobas 6000 e 601 modules, 3 cobas 8000 e 801 modules, and one cobas 8000 e 602 module.The events involved a total of 7 patients with the following: 7 erroneous results for the elecsys tsh assay.Three patients' ages ranged from 26 to 64 years.There were 2 females and 2 males.
Additional Manufacturer Narrative
For one of the pending events, the sample was provided for the investigation.The investigation confirmed the results generated at the customer site.The investigation detected a high biotin concentration in the sample which is a known interference.For the second pending event, the investigation confirmed the results generated at the customer site and no interference factors for tsh were detected.For the third pending event, the sample was provided for the investigation and an interfering factor to a portion of an assay component was detected.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: 8549715
• Report Number: 1823260-2019-90119
• Device Sequence Number: 2169248
• Product Code: JLW
• UDI-Device Identifier: 04015630899661
• UDI-Public: 4015630899661
• 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: 37338601, 36541701
• 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