MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 III ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number	07976887190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer questioned results for 1 patient tested for elecsys ft4 ii (ft4 ii), tsh, anti-tpo and anti-tshr on a cobas e 801 module.Refer to the associated medwatches with the following patient identifiers: (b)(6).Between (b)(6) 2017 and (b)(6) 2018 the patient had increased ft4 ii results (29-52 pmol/l) and low tsh results (0.04 - 0.17 mie/l) in 14 different samples from the patient when tested on the e801 module.Anti-tpo results were > 600 ie/ml in 6 different samples from the patient when tested on the e801 module.The patient previously had negative anti-tshr results in 2 different samples when tested by the (b)46) method, however, when the customer changed to the roche method in (b)(6) 2017, the patient had positive anti-tshr in 7 different samples when tested on the e801 module.The actual results were not provided.The roche results were reported outside of the laboratory where the patient was diagnosed with hyperthyroidism and treatment was started with neo-mercazole in (b)(6) 2017.The customer suspects an interference in the patient sample as the patient's clinical symptoms do not agree with the results.The customer sent 3 patient samples obtained in (b)(6) 2018 and (b)(6) 2018 for testing by the abbott architect method.Discrepant results were identified for ft4 ii and tsh between the e801 module and the abbott method.Refer to attached data for the patient comparison results.After the patient samples were tested by the abbott architect method, neo-mercazole treatment was stopped.There was no allegation that an adverse event occurred.The e801 module serial number was (b)(4).
Additional Manufacturer Narrative
One sample from the patient was submitted for investigation.An interfering factor was not identified.A product problem was not found.Investigations are ongoing.
Additional Manufacturer Narrative
It was clarified that the ft4 ii results from the initial report were actually elecsys ft4 iii (ft4 iii) results.Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed.This interference is covered in product labeling.

• Brand Name: ELECSYS FT4 III ASSAY
• Common Device Name: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7706293
• Report Number: 1823260-2018-02414
• Device Sequence Number: 1365607
• Product Code: CEC
• UDI-Device Identifier: 04015630939725
• UDI-Public: 04015630939725
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K131244
• 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): 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: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 07/04/2018; 07/04/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 08/14/2018; 09/04/2018
• 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: LIPITOR; NEO-MERCAZOLE; PREDNISOLONE
• Patient Age: 70 YR