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

Model Number E801

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received questionable results for one patient sample tested with elecsys t3, the elecsys t4 assay, and the elecsys ft4 ii assay on a cobas 8000 e 801 module.Of the mentioned tests, the sample had discrepant ft4 results.No erroneous results were reported outside of the laboratory.The primary tube of the sample was initially tested on the e 801 analyzer, resulting with a ft4 value of 2.0 ng/dl.The sample was repeated on a roche diagnostics elecsys e170 modular analytics immunoassay analyzer on (b)(6) 2018, resulting with a ft4 value of 4.0 ng/dl.The sample was repeated on a second e170 analyzer on (b)(6) 2018, resulting with a ft4 value of 4.8 ng/dl.The 4.8 ng/dl was believed to be correct and was reported outside of the laboratory to the patient.The sample was transferred to a sample cup and tested on the e 801 analyzer on (b)(6) 2018, resulting with a ft4 value of 2.10 ng/dl.The sample cup was also repeated on the first e170 analyzer on (b)(6) 2018, resulting with a ft4 value of 4.03 ng/dl.No adverse events were alleged to have occurred with the patient.The ft4 reagent lot number was 265662.The reagent expiration date was asked for, but not provided.The alarm trace showed a sample short alarm around the time the sample was pipetted.Quality controls were within range.

Manufacturer Narrative

A sample from the patient was provided for investigation.Investigations of the sample were able to duplicate the values obtained by the customer.It was determined that the sample contained a factor which interferes with a component of the ft4 assay.This limitation is covered in product labeling.Falsely elevated ft4 values were generated with both types of roche analyzers (e 801 and e 170).The differences in ft4 values between the analyzers most likely relates to the small differences in overall physical reaction conditions of the different types of analyzers.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
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7938219
• MDR Text Key: 123834690
• Report Number: 1823260-2018-03428
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 04015630946198
• UDI-Public: 04015630946198
• Combination Product (y/n): N
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E801
• Device Catalogue Number: 07682913001
• Device Lot Number: 265662
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO MEDICATION
• Patient Age: 26 YR