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

Catalog Number	07027885190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys tsh assay, the elecsys ft4 iii assay, elecsys ft3 iii, the elecsys t4 assay, elecsys t3, and the elecsys anti-tshr immunoassay on a cobas 8000 e 801 module and a second e 801 module used for investigation.No incorrect results were reported outside of the laboratory.This medwatch will apply to the t4 assay.Please refer to the medwatch with patient identifier (b)(4) for information related to the tsh assay, refer to the medwatch with patient identifier (b)(4) for information related to the ft4 assay, refer to the medwatch with patient identifier (b)(4) for information related to the ft3 assay, refer to the medwatch with patient identifier (b)(4)for information related to the t3 assay, and refer to the medwatch with patient identifier (b)(4) for information related to the anti-tshr assay.Refer to the attachment for all patient data.Values highlighted in yellow are discrepant.The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2019.The sample was repeated using the architect method (for tsh, ft4, ft3, t4, t3) and yamasa method (for anti-tshr).The sample was provided for investigation where it was tested on a second e 801 analyzer on (b)(6) 2019.The serial number of the customer's e 801 analyzer was requested, but not provided.The serial number of the e 801 analyzer used for investigation is (b)(4).T4 reagent lot number 415431, with an expiration date of october 2020 was used on this analyzer.
Additional Manufacturer Narrative
The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS T4 ASSAY
• Common Device Name: RADIOIMMUNOASSAY, TOTAL THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 9384224
• Report Number: 1823260-2019-90266
• Device Sequence Number: 11323407
• Product Code: CDX
• UDI-Device Identifier: 04015630939800
• UDI-Public: 04015630939800
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 12/23/2019

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: 07027885190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 12/23/2019
• 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: THYRADIN