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

Catalog Number	07027397190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer questioned high results for 2 patients tested for elecsys ft4 ii on a cobas e801 module.Patient 1: on (b)(6) 2018 patient 1 had an ft4 ii result of 38.6 pmol/l.On (b)(6) 2018 patient 1 had an ft4 ii result of 37.4 pmol/l.On (b)(6) 2018 patient 1 had an ft4 ii result of 44.0 pmol/l.On (b)(6) 2018 patient 1 had an ft4 ii result of 44.3 pmol/l.The sample from (b)(6) 2018 was sent to another laboratory using the vitros method and the ft4 result was 13.4 pmol/l.Patient 2 (male, (b)(6)): on (b)(6) 2018 patient 2 had an ft4 ii result of 38.9 pmol/l.On (b)(6) 2018 patient 2 had an ft4 ii result of 44.7 pmol/l.Patient 2 was tested using the vitros method and the ft4 result was 13.1 pmol/l.It is not known if this result is from a new sample or the sample from (b)(6) 2018.The high results from the e801 module were reported outside of the laboratory.There was no allegation that an adverse event occurred.The e801 module serial number was (b)(4).
Additional Manufacturer Narrative
The statement from the initial report for patient 2 initially said: "patient 2 was tested using the vitros method and the ft4 result was 13.1 pmol/l." the affiliate clarified the method that was used.The statement should read: "patient 2 was tested by the abbott architect method and the ft4 result was 13.1 pmol/l.".
Additional Manufacturer Narrative
Two (2) samples of 2 different patients were investigated by the manufacturer.Patient 1: the high ft4 value, generated at the customer site, was confirmed at roche diagnostics.No assay interfering factors could be detected regarding the observed differences in ft4 values generated with the roche assay and siemens centaur assay.Patient 2: an interfering factor was detected in the sample.In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.No product problem could be found.

• Brand Name: ELECSYS FT4 II ASSAY
• Common Device Name: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7919355
• Report Number: 1823260-2018-03346
• Device Sequence Number: 19281932
• Product Code: CEC
• UDI-Device Identifier: 04015630939725
• UDI-Public: 04015630939725
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 12/26/2018

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: 07027397190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 09/12/2018; 09/12/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 11/07/2018; 12/26/2018
• 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: NEITHER PATIENT TAKES MEDICATION
• Patient Age: 53 YR