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

Catalog Number	07028091190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred in: (b)(6).
Event or Problem Description
The customer complained of questionable elecsys tsh assay results for 10 patient samples tested on a cobas 8000 e 801 module.It was unknown if the erroneous results were released outside of the laboratory.There was no allegation of an adverse event.The cobas e801 serial number was (b)(4).Review of the analyzer alarm history did not give any indication of an issue.The customer was using rack adapters.The field engineering specialist inspected the analyzer and did not find any problems.The discrepant results started to occur when the customer switched to a new pack of reagent.Based on the information provided a definitive root cause could not be determined.

• Brand Name: ELECSYS TSH ASSAY
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7790081
• Report Number: 1823260-2018-02740
• Device Sequence Number: 16441290
• Product Code: JLW
• UDI-Device Identifier: 04015630939831
• UDI-Public: 04015630939831
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K961491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 07028091190
• Device Lot Number: 283556
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2018
• Initial Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1