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 10/17/2014

Event Type  malfunction  

Event Description

The customer reported that they received questionable thyrotropin (tsh), free triiodothyronine (ft3), and free thyroxine (ft4) results for one patient sample run on an e module.The sample was provided for investigation and during investigations, the sample was tested with the same assays on a modular pe analyzer and an e411 analyzer.During investigation, the sample was also tested on a centaur analyzer.The results for all three assays were found to be erroneous when the customer e module analyzer results were compared to the results from the centaur analyzer.The ft3 assay was also found to have erroneous results when the results from the modular pe analyzer and e411 analyzer from the investigation site were compared.It was asked, but it is not known which results were reported outside of the laboratory.This medwatch will address only the ft4 assay.Patient identifier (b)(6) for additional information on the tsh assay and (b)(6) for additional information on the ft3 assay.The initial ft4 result was 1.89 ng/dl on the e module at the customer site on (b)(6) 2014.For investigation, the sample was tested on modular pe analyzer on (b)(6) 2014, resulting as 1.80 ng/dl.For investigation, the sample was also tested on an e411 analyzer on (b)(6) 2014, resulting as 1.63 ng/dl.For investigation, the sample was also tested on a centaur analyzer on (b)(6) 2014, resulting as 1.5 ng/dl.The patient was not adversely affected.It was asked, but the serial number of the e module used at the customer site was not provided.The serial number of the modular pe analyzer used at the investigation site was (b)(4).It was asked, but the serial number of the e411 analyzer used at the investigation site was not provided.The ft4 reagent lot number used at the investigation site was (b)(4).The expiration date of the ft4 reagent used at the investigation site was asked for, but not provided.Investigations have determined that with respect to the location of all values versus the respective normal reference ranges used, the values generated with the roche analyzers (e module at customer site and modular pe/e411 at investigation site) result in values slightly above the normal reference range.The value measured with the centaur analyzer is within the normal reference range of the assay.The differences in values for the ft4 assay could not be clarified as the sample could not be made available for further analysis.From a positioning of the values versus the normal reference range point of view, the difference in the ft4 values could not be elucidated as no additional sample was available for further analysis.A general reagent issue could not be detected.Given the different setups of all assays, the antibodies used, and the variances in reference methods, differences in values may occur when comparing values of assays from different vendors.

Manufacturer Narrative

This event occurred in (b)(6).

• 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: 4323376
• MDR Text Key: 14880342
• Report Number: 1823260-2014-09873
• 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
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• 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
• Date Manufacturer Received: 11/17/2014
• 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