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 10/08/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).- (b)(4).

Event Description

The customer received questionable low free thyroxine (ft4) results for one patient sample from an analytical e module.The results were reported out and were questioned by the physician as they did not match the patient's clinical condition.The sample was submitted for investigation and was tested on a modular analyzer and a centaur analyzer.Of the data provided, the results for ft4 and free triiodothyronine (ft3) were discrepant.Refer to the attachment to the medwatch for all patient data.Refer to the medwatch with patient identifier (b)(6) for the ft3 assay.Information concerning if the patient was adversely affected was requested but was not provided.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.From the information provided, a general reagent issue was not likely.Given the different setups of all assays, the antibodies used and the variances in reference methods, differences in values may occur when comparing thyroid assays from different vendors.The results of all thyroid parameters vary in function of age, gender and other population characteristics which need to be taken into account when analyzing the results.

• 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: 5177888
• MDR Text Key: 29247336
• Report Number: 1823260-2015-04398
• 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: Health Professional
• Type of Report: Initial
• Report Date: 10/26/2015

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: 10/08/2015
• Initial Date FDA Received: 10/26/2015
• 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
• Treatment: BETAMETHASONE
• Patient Age: 039 YR