MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T4 ASSAY; RADIOIMMUNOASSAY, TOTAL THYROXINE

Catalog Number	12017709122
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2018
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 tested on a cobas 6000 e 601 module compared to competitor (abbott and ria) results.The customer stated that the patient's elecsys t3 and elecsys t4 assay results were similar before and after t3/t4 supplementation and they did not consider that reasonable.From the data provided, a reportable malfunction was provided for t3, t4, elecsys ft4 ii assay, and elecsys tsh assay.The specific date of testing for the data that is a reportable malfunction is not known, but clarification has been requested.This medwatch will cover the t4 data.Refer to medwatch with patient identifier (b)(6) for information on the t3 results.Refer to medwatch with patient identifier (b)(6) for information on the ft4 ii results.Refer to medwatch with patient identifier (b)(6) for information on the tsh results.The customer did not provide the thyroid data for the time period before the patient was taking t3/t4 supplements.The customer performed multiple dilutions of different dilution factors using two different diluents, but product labeling does not support dilution testing.The erroneous results were not released outside of the laboratory.There was no allegation of an adverse event.The cobas e601 serial number was (b)(4).The investigation is currently ongoing.
Additional Manufacturer Narrative
The patient sample was not available for further investigation.The investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
The specific date of testing for sample a was not provided, but it was mentioned that the testing on the customer's cobas e602, the abbott system, and the ria method were within three days of each other.

• Brand Name: ELECSYS T4 ASSAY
• Common Device Name: RADIOIMMUNOASSAY, TOTAL THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7790435
• Report Number: 1823260-2018-02742
• Device Sequence Number: 11060008
• Product Code: CDX
• UDI-Device Identifier: 04015630912728
• UDI-Public: 04015630912728
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K961490
• 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,Followup
• Report Date (Section B): 10/08/2018

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: 12017709122
• Device Lot Number: 248077
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 07/30/2018; 07/30/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 08/29/2018; 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: T3/T4 SUPPLEMENTS
• Patient Age: 53 YR