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

Catalog Number ASKU

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 12/10/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The physician complained of erroneous results for 1 patient sample tested for thyrotropin (tsh).The customer is comparing results from their architect instrument to a roche instrument from an external laboratory.The tsh results from the architect instrument were reported outside of the laboratory where they were questioned by the physician.The physician requested investigation of 1 patient sample.The physician suspects macro tsh interference in the sample.Based on the data provided, erroneous free thyroxine (ft4) and free triiodothyronine (ft3) results were also identified.The sample was submitted for investigation.This medwatch will cover ft4.Refer to medwatch with patient identifier (b)(6) for information on the tsh erroneous results and patient identifier (b)(6) for information on the ft3 erroneous results.No adverse event has been reported.The serial number for the roche instrument used at the external laboratory was not provided.Refer to the attachment to the medwatch for the serial numbers and reagent lot information used at the investigation site.

Manufacturer Narrative

A specific root cause could not be identified for the differences in the ft4 results.Assays from different manufacturers can generate different values.This relates to the overall setup of the assay, the antibodies used and differences in reference materials/methods and the standardization method used.

• 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: 5331573
• MDR Text Key: 34593569
• Report Number: 1823260-2015-06138
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: ASKU
• 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,Followup
• Report Date: 02/18/2016

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2016
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR