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	05/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
The customer complained of questionable elecsys tsh assay, elecsys ft4 ii assay, and elecsys ft3 iii results for five separate samples from 1 patient that were not matching the patient's clinical picture.The testing was performed on a cobas 8000 e 801 module with a serial (b)(4).Medwatches related to this issue have (b)(6).The customer stated that the patient does not have any "thyroid symptoms" and that they suspect that there is an interference.The questionable results were reported outside of the laboratory.There was no allegation of an adverse event.The investigation is currently ongoing.
Additional Manufacturer Narrative
There is no patient sample available for further investigation.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: 7690204
• Report Number: 1823260-2018-02340
• Device Sequence Number: 13654570
• Product Code: JLW
• UDI-Device Identifier: 04015630939831
• UDI-Public: 04015630939831
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 09/17/2018

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: 06/28/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 09/17/2018
• 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: ANTI-PD1; CTLA 4
• Patient Age: 49 YR