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

Catalog Number 07976836190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer complains of discrepancies in ft3 and ft4 results when comparing an unspecified number of patient results from the elecsys to results from the architect.When measuring values in a 1 step method, false high values are experienced due to the influence of "coexisting substances".Samples which had "sitsh" like findings with a 1 step method were measured by a 2 step method.Six "sitsh-like" specimens measured in the 1 step method had similar findings when measured with a 2 step method, but 21 cases were not "sitsh-like".Polyethylene glycol (peg) treatment of these 21 cases resulted in a decreased recovery rate in 2 cases.In addition, "segsh-like" specimens were also subjected to peg treatment in the same way for ft4 and ft3, which resulted in single abnormally high values, and a decrease in recovery rate was observed.All of the samples with a decreased recovery rate by the peg treatment were samples which had autoantibodies.This suggests that antibodies against t3 and t4 were affected by the reaction process.Those which become abnormally high or "sitsh like" by the 1 step method would need to be examined by the 2 step method in order to account for differences caused by the influence of autoantibodies and the like.The customer provided data for a total of 19 samples from 5 different patients tested for multiple assays on the roche diagnostics elecsys e170 modular analytics immunoassay analyzer (e170).Erroneous results were reported outside of the laboratory for a total of 12 of these samples.Results from the following assays were affected: elecsys tsh assay (tsh), elecsys ft3 iii (ft3), elecsys ft4 ii assay (ft4ii), and elecsys ft4 iii assay (ft4iii).Patient identifiers for information related to each affected assay: (b)(6).Refer to the attachment for all patient data.Values highlighted in yellow are erroneous.Samples were tested on the customers e170 analyzer and repeated on the architect analyzer.Some samples were also tested on the e170 to compare ft4ii and ft4iii values.No adverse events were alleged to have occurred with the patients.The e170 analyzer used at the customer site was (b)(4).

Manufacturer Narrative

Further investigations were performed on the sample dated (b)(6) 2018 from patient a and samples dated (b)(6) 2018 and (b)(6) 2018 from patient b.Investigations of these samples confirmed they contained an interfering factor to a component of the ft3 and ft4ii assays.This limitation is covered in product labeling.The effect of the interfering factor is eliminated with the ft4iii assay.All the remaining samples could not be provided for investigation.For these samples, the investigation was unable to find a definitive root cause.For the mathematical differences in ft4iii values generated from the (b)(6) 2018 sample from patient a and the sample from patient d with the roche and abbott assays, this can be explained by the fact that assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials, and differences in standardization methodology used.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.

Manufacturer Narrative

Eleven of the patient samples were provided for investigation where they were tested on a cobas 8000 e 602 module (e602) and a cobas e 411 immunoassay analyzer (e411).Refer to the attachment for all patient data.The e602 analyzer used for investigation was 1286-07.Ft4iii reagent lot number 304692, with an expiration date of january 2019 was used on this analyzer.The e411 analyzer used for investigation was 1368-02.The ft4iii reagent lot number and expiration date used on this analyzer were not provided.

Manufacturer Narrative

The sample for patient d was repeated on a centaur analyzer, resulting with the following values: tsh = < 0.008 uiu/ml, ft4 = 6.34 ng/dl, ft3 = > 20.0 pg/ml.The data measured on the e602 and e411 analyzers used for investigation has been corrected.Please see the attachment for the correct data.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7578232
• MDR Text Key: 110865537
• Report Number: 1823260-2018-01778
• Device Sequence Number: 1
• Product Code: CEC
• 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,Followup,Followup
• Report Date: 08/31/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 07976836190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/07/2018
• Supplement Dates Manufacturer Received: 05/18/2018; 05/18/2018; 05/18/2018
• Supplement Dates FDA Received: 06/22/2018; 07/12/2018; 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1