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

Catalog Number	07028091190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred in: (b)(6).
Event or Problem Description
The customer complained of questionable thyroid results for 1 patient sample tested on a cobas 8000 e 801 module compared to the results from both a wako and architect instrument.From the data provided, a reportable malfunction was provided for elecsys tsh assay and elecsys ft3 iii.This medwatch will cover the tsh.Patient identifier (b)(6) for information on ft3 iii.The discrepant results are highlighted.The erroneous results were released outside of the laboratory.There was no allegation of an adverse event.The cobas e801 serial number used at the customer's site was (b)(4).The cobas e801 serial number used at the investigation site was (b)(4).The ft3 iii reagent lot used at the investigation site was lot 314824 with an expiration date of may-2019.The tsh reagent lot used at the investigation site was lot 331814 with an expiration date of aug-2019.The investigation is currently ongoing.
Additional Manufacturer Narrative
From the information provided, a general reagent issue most likely can be excluded.To the differences of the tsh and ft3 values generated with the analyzers from roche diagnostics, abbott and wako: it needs to be taken into account that assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used.The investigation did not identify a product problem.The cause of the event 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: 7926428
• Report Number: 1823260-2018-03392
• Device Sequence Number: 2305489
• Product Code: JLW
• UDI-Device Identifier: 04015630939831
• UDI-Public: 4015630939831
• 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,Followup
• Report Date (Section B): 10/09/2018

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?: Yes
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR