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

Catalog Number 06437281190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer reported that they received erroneous results for one patient sample tested for free triiodothyronine (ft3) and free thyroxine (ft4).This medwatch will cover ft4.Refer to the medwatch with (b)(6) for information referring to ft3.The sample was initially tested at the customer site on an e602 analyzer.At the customer site, the patient sample was also treated with polyethylene glycol (peg) and measured on the e602 analyzer.The customer repeated sample measurements on (b)(6) 2016 on the e602 analyzer, an architect analyzer, and a centaur analyzer.The results obtained by the customer were reported outside of the laboratory with a disclaimer indicating that the results may be affected by an interfering factor.During investigations, the patient sample was tested on a modular-pe (mod-pe) analyzer and an e411 analyzer.Refer to the attachment for the specific patient result values.The patient was not adversely affected.The e602 analyzer serial number used at the customer site was asked for, but not provided.The modular-pe analyzer used for investigation purposes was serial number (b)(4).The ft4 reagent lot number used on this analyzer was 125827, with an expiration date of january 2017.The e411 analyzer used for investigation purposes was serial number (b)(4).The ft4 reagent lot number used on this analyzer was 125827, with an expiration date of january 2017.A specific root cause could not be determined based on the provided information.There was no sample volume remaining for further investigations.A general reagent issue could not be detected.The values generated with the modular-pe analyzer used for investigations and the e602 analyzer at the customer site are above the normal reference range of the assay.The value generated with the e411 analyzer used for investigations is slightly above the normal reference range of the assay.The values generated with the architect and centaur analyzers are within the normal reference ranges of the respective assays.A biological component may be present in the sample that may differently interact with the assay components during the pre-wash procedure.The prewash procedure is in use with the large type of analyzers from roche diagnostics (such as the e602 module and the modular-pe).This may result in discrepant results generated with the large type of analyzers versus the smaller type of analyzers (such as the e411 analyzer) that do not use the prewash procedure.The centaur and architect analyzers also do not have a pre-wash procedure.

Manufacturer Narrative

A new sample was collected from the same patient and tested at the customer site on (b)(6) 2017 on an unknown roche analyzer.The customer complained that the ft3 result did not meet the clinical condition of the patient.The ft3 value obtained at the customer was erroneous.It was asked, but it is not known if the erroneous value was reported outside of the laboratory.The sample was provided for investigation, where it was tested on an e602 analyzer and an e411 analyzer.No adverse events were alleged to have occurred with the patient.The model and serial number of the roche analyzer used at the customer site was asked for, but not provided.The serial numbers of the e602 and e411 analyzers used for investigation was asked for, but not provided.

• 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: 5776727
• MDR Text Key: 49053736
• Report Number: 1823260-2016-00868
• 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
• Type of Report: Initial,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• 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?: No
• Date Manufacturer Received: 06/23/2016
• 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
• Patient Age: 38 YR