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	05/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
The customer stated that they received erroneous results for two samples from one patient and one sample from a second patient tested for elecsys ft3 iii and the elecsys ft4 ii assay on a cobas 8000 e 801 module at the customer site and an unknown roche cobas analyzer at a second site.The erroneous results were reported outside of the laboratory.The endocrinologist complained that the ft3 and ft4 results were implausibly high compared to results generated on an abbott architect analyzer at the second site.The customer believes that an antibody interferent is present in the samples.This medwatch will apply to the ft4 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to ft3.The erroneous data is highlighted in yellow.For patients 1 and 2, samples each dated(b)(6) 2018 were tested at the customer site on the e801 analyzer.The samples were then sent to a second site for testing on an unknown roche cobas analyzer and an abbott architect analyzer.Ft3 and ft4 results for these samples were within reference ranges for the abbott assays.At the second site, the samples were also treated with heterophilic antibody blocking tubes (hbt) and tested on both the roche cobas and abbott architect.Further experiments were performed at the customer site for a second sample from patient 1 (dated (b)(6) 2018).For these experiments, the sample was diluted with an nacl solution and was also treated with polyethylene glycol (peg), then measured on the e801 analyzer.No adverse events were alleged to have occurred with the patients.The serial number of the e801 analyzer used at the customer site is (b)(4).The model and serial number of the roche cobas analyzer used at the second site were asked for, but not provided.
Additional Manufacturer Narrative
No sample was provided for patient 2, therefore a root cause to the observed discrepancies cannot be determined.Upon investigation of the patient sample, the presence of an interfering factor causing the falsely elevated values for the ft3iii, t3, ft4 and t4 assay in the investigation of patient sample 1 could be confirmed.This interference is covered in product labeling: 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.

• 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: 7772395
• Report Number: 1823260-2018-02673
• Device Sequence Number: 19180458
• Product Code: CEC
• UDI-Device Identifier: 04015630939725
• UDI-Public: 04015630939725
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• 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: 07027397190
• Device Lot Number: 303203
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 08/10/2018
• 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