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

Catalog Number 06437281190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for one patient sample tested for elecsys ft3 iii (ft3) and the elecsys ft4 ii assay (ft4) on a cobas 8000 e 602 module (e602).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 the ft3 assay.The customer initially tested the sample on their e602 analyzer.The sample was provided for investigation, where it was tested on a cobas 6000 e 601 module (e601) and a cobas e 411 immunoassay analyzer (e411).The patient was not adversely affected.The serial number of the e602 analyzer used at the customer site was asked for, but not provided.The e601 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 180429, with an expiration date of 07/30/2017 was used for testing on this analyzer.The e411 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 180429, with an expiration date of 07/30/2017 was used for testing on this analyzer.A specific root cause could not be determined based on the provided information.There was not enough sample volume remaining for further investigations.Additional information for further investigation was requested but not provided.A general reagent issue could not identified based upon the information provided for investigation.All values for ft4 are above the upper level of the normal reference range of the assay.For the observed differences in values between the e601 and e602 analyzers and the e411 analyzer for the ft4 and ft3 assays, a biological component may be present in the sample that may interact differently with the assay components during the prewash procedure.The pre-wash procedure is used on the e601 and e602 analyzers, but is not used on the e411 analyzer.

Manufacturer Narrative

A new sample was collected from the patient and had the following values when tested on the customer's e602 analyzer : tsh (uiu/ml): 0.53, 0.43, ft4 (ng/dl): > 7.77, > 7.77, ft3 (pg/ml): 11.9, 12.9.This sample will be provided for further investigations.No adverse events were alleged to have occurred with the patient.

Manufacturer Narrative

Upon investigation of the new patient sample, it was determined that the sample contains an interferent to the streptavidin used in the ft3 and ft4 reagents.This limitation is covered in product labeling.

• 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: 6324956
• MDR Text Key: 67237356
• Report Number: 1823260-2017-00278
• 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,Followup
• Report Date: 05/19/2017

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?: No
• Initial Date Manufacturer Received: 01/23/2017
• Initial Date FDA Received: 02/12/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/28/2017; 05/19/2017
• 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