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

Catalog Number 06437281190

Device Problem Low Test Results (2458)

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

Event Date 07/09/2015

Event Type  malfunction  

Event Description

The customer received questionable thyroid results for four patient samples from a cobas e602 analyzer.The specific date of testing was not provided.The samples were submitted for investigation and were tested on a cobas 8000 analyzer on (b)(6) 2015 and a centaur analyzer on (b)(6) 2015.Of the data provided, only the results for one patient sample were discrepant.Refer to the medwatchs with patient identifiers (b)(6) for the other assays involved.Information concerning if any erroneous result was reported outside the laboratory or if the patient was adversely affected was requested but was not provided.The investigation could not determine a specific root cause as no sample was available for further testing.Additional information for further investigation was requested but was not provided.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

A new sample from the patient was provided for investigation.The values obtained by the customer and those obtained during initial investigations could not be reproduced.The sample was investigated for the presence of interfering factors to the assays and no interfering factors were identified within the sample.

Manufacturer Narrative

Additional sample from the patient was submitted for investigation.The customer's results could not be reproduced.Based on the results of testing on different analyzers, a prewash interference was confirmed which most likely caused the falsely elevated values.Product labeling documents in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 4944033
• MDR Text Key: 6254724
• Report Number: 1823260-2015-03873
• 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,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2015

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
• Event Location: Laboratory
• Initial Date Manufacturer Received: 07/13/2015
• Initial Date FDA Received: 07/27/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/12/2016; 07/07/2016
• 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
• Patient Sequence Number: 1