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 11/12/2014

Event Type  malfunction  

Event Description

The customer received questionable thyrotropin (tsh), free thyroxine (ft4) and free triiodothyronine (ft3) results for an unknown number of patient samples.The customer tested the patient samples on a cobas 8000 e602 analyzer.As part of the investigation, the samples were tested on a cobas e411 analyzer and a centaur analyzer (clia).Of the data provided for 12 patient samples, only the results for 11 patient samples were discrepant.Refer to the attachment to the medwatch for all patient data.Information concerning which result was reported outside the laboratory was requested, but was not provided.No adverse event was reported.(b)(6).

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

Six of the patient samples were submitted for further investigation and the customer's ft4 and ft3 results were reproduced.For sample 5, an interfering factor to streptavidin was found.This interference with the assay is documented in product labeling.

Manufacturer Narrative

The remaining five patient samples, were analyzed with and without the assay prewash and no difference was found between the results.Based on these results, an interfering factor to streptavidin was excluded.A specific root cause could not be identified for these samples.

• 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) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4342060
• MDR Text Key: 5199041
• Report Number: 1823260-2014-10125
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2015
• Device Catalogue Number: 06437281190
• Device Lot Number: 177593
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 12/05/2014
• 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