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

Catalog Number 06437281190

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer stated that they received erroneous results for three patient samples tested for the elecsys tsh assay (tsh), elecsys ft3 iii (ft3), and the elecsys ft4 ii assay (ft4) on a cobas 6000 e 601 module (e601).It was asked, but it is not known if any erroneous results were reported outside of the laboratory.This medwatch will apply to the ft4 assay.Please refer to the medwatch with (b)(6) for information related to tsh and refer to the medwatch with (b)(6) for information related to ft3.The samples were tested on the e601 analyzer and on an architect analyzer.The values highlighted in yellow are erroneous.The samples were also provided for investigations, where they were tested on a cobas 8000 e 602 module (e602) and cobas e 411 immunoassay analyzer.The ft4 units of measure were also provided as ng/ml.A clarification of the correct units has been requested.No adverse events were alleged to have occurred with the patients.The e601 analyzer serial number used at the customer site was (b)(4).The e602 analyzer and e411 analyzer serial numbers used for investigation were asked for, but not provided.Ft4 reagent lot number 246825, with an expiration date of june 2018 was used on the e602 analyzer.Ft4 reagent lot number 215455, with an expiration date of march 2018 was used on the e411 analyzer.

Manufacturer Narrative

It has been confirmed that all three samples are from the same patient.Data for a fourth sample from this same patient was also provided.This sample was provided for investigation where it was tested on an e602 analyzer and an e411 analyzer.The results for this sample are as follows: tsh: e602 = 0.702 uiu/ml, e411 = 0.730 uiu/ml.Ft4: e602 = 1.77 ng/dl, e411 = 1.81 ng/dl.Ft3: e602 = 3.28 pg/ml, e411 = 3.26 pg/ml.Each of the four samples were collected on the following dates: sample 1 = (b)(6) 2017, sample 2 = (b)(6) 2017, sample 3 = (b)(6) 2017, sample 4 = (b)(6) 2017.

Manufacturer Narrative

It is very unlikely that an interfering factor appears and disappears in samples collected from the same patient only a few days apart.Therefore, a sample mix up may have occurred.For the differences between the values generated on the roche diagnostics and abbott platforms, it needs to be taken into account that assays from different vendors can generate different values.This is related to the overall setups of the assays, the antibodies used, differences in reference materials, and differences in the 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

Four samples from the patient were provided for investigation.The samples dated (b)(6) 2017, (b)(6) 2017, and (b)(6) 2017 were analyzed for potential interfering factors.An interfering factor against a component of the reagents was detected in the sample dated (b)(6) 2017.This limitation is covered in product labeling.No interfering factors could be detected in the samples dated (b)(6) 2017 and (b)(6) 2017.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6893145
• MDR Text Key: 89501477
• Report Number: 1823260-2017-02094
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/13/2017

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: 06437281190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2017
• Initial Date FDA Received: 09/26/2017
• Supplement Dates Manufacturer Received: 09/05/2017; 09/05/2017; 09/05/2017
• Supplement Dates FDA Received: 09/29/2017; 11/01/2017; 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1