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

Catalog Number	07028091190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
The customer received questionable thyroid results for two samples from one patient from the cobas 8000 e 801 module.The sample was then tested on an architect analyzer and submitted for investigation where it was tested on a cobas 8000 e 801 module, cobas 6000 e602 module, and a cobas e 411 immunoassay analyzer.Refer to the medwatch with the following patient identifiers: (b)(6) elecsys tsh assay; (b)(6) elecsys ft4 assay; (b)(6) elecsys ft3 iii.The erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The investigation did not identify a product problem.The cause of the event could not be determined as no sample was available for further investigation.From the information provided, a general reagent issue could most likely be excluded.The differences in the values most likely relate to the different setups of the assay, the different antibodies used, and the different standardization materials/procedures used.

• 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: 7991559
• Report Number: 1823260-2018-03788
• Device Sequence Number: 1487962
• 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): 10/22/2018

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 Catalogue Number: 07028091190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR