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 Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for one patient sample tested for elecsys ft3 iii (ft3), the elecsys ft4 ii assay (ft4), and the elecsys tsh assay (tsh) 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.Patient identifier (b)(6) for information related to the ft3 assay and refer to the medwatch.Patient identifier (b)(6) for information related to the tsh assay.Refer to the attachment for all patient data.The sample was initially tested at the customer site on an e602 analyzer.The sample was sent to another laboratory for testing on a siemens centaur analyzer.The sample was also provided for investigation, where it was tested on a second e602 analyzer, a cobas e 411 immunoassay analyzer (e411), and a cobas 8000 e 801 module (e801).It was asked, but it is not known if the patient was adversely affected.No adverse events were alleged to have occurred with the patient.The serial number of the e602 analyzer used at the customer site was asked for, but not provided.The e602 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 265631 , with an expiration date of 30-sep-2018 was used on this analyzer.The e411 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 257857, with an expiration date of 31-jul-2018 was used on this analyzer.The e801 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 225159, with an expiration date of 31-may-2018 was used on this analyzer.Calibrations and controls measured for the investigation measurements were ok.A specific root cause could not be determined based on the provided information as there was no more sample volume available for further investigation.A general reagent issue can most likely be excluded.For the differences in ft3 and ft4 values generated with the analyzers from roche diagnostics, a biological component may be present in the sample that may differently interact with the assay components on the analyzers involved.This may result in discrepant results generated with different types of roche analyzers.A presence of such a factor would also explain a difference in results between roche and siemens platforms.The high ft4 value generated with the e602 used during investigations may have been caused by a reagent specific issue such as bubbles or foam on the reagent surface.

• 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: 7133152
• MDR Text Key: 96036948
• Report Number: 1823260-2017-03061
• 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
• Report Date: 12/20/2017

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: 12/05/2017
• Initial Date FDA Received: 12/20/2017
• 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