MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO; SYSTEM, TEST, THYROID AUTOANTIBODY

Catalog Number	06368590190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
The customer received questionable thyroid results for one patient from a cobas 6000 e 601 module.The serial number was requested but was not provided.The patient has dwarfism and had been injected with recombinant human growth hormone beginning in (b)(6) 2017.An interference was suspected as the results portray hyperthyroidism however the patient had no thyroid symptoms and appeared normal.The results of the patient's thyroid function tests were normal on (b)(6) 2018.However, with sample from (b)(6) 2018, the elecsys ft3 iii and elecsys ft4 ii assay concentrations were both increased.The samples were tested with the beckman, siemens, and abbott methods and the results were discrepant for ft3, ft4, elecsys tsh assay, and roche diagnostics cobas elecsys anti-tpo.This medwatch is for the anti-tpo assay.Refer to the medwatches with the following patient identifiers for the other assays involved: (b)(6).No erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.
Additional Manufacturer Narrative
A sample was requested for investigation but cannot be provided.The investigation was unable to find a definitive root cause.

• Brand Name: ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
• Common Device Name: SYSTEM, TEST, THYROID AUTOANTIBODY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7800833
• Report Number: 1823260-2018-02793
• Device Sequence Number: 2726030
• Product Code: JZO
• UDI-Device Identifier: 04015630929702
• UDI-Public: 04015630929702
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051890
• 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): 09/04/2018

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: 06368590190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR