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

Catalog Number 06437281190

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer questioned results from 1 patient sample tested for thyrotropin (tsh), free thyroxine (ft4 ii) and free triiodothyronine (ft3).Of the data provided, erroneous ft4 and ft3 results were identified between the customer's e601 analyzer and an abbott analyzer.The erroneous results were reported outside of the laboratory.The physician did not trust the results as they did not fit the patient's clinical history.The physician requested repeat testing on a different system.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the ft3 erroneous results.Refer to the attached data for patient results.No adverse event occurred.The e601 analyzer serial number was (b)(4).

Manufacturer Narrative

Date of event was clarified to be (b)(6) 2015.It was clarified that the patient results from (b)(6) 2015 were from a different sample.The patient results from (b)(6) 2015 were from the same sample.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.Based on the available data, a general calibration or reagent issue can be excluded.Quality controls were acceptable.A possible root cause could be an interfering factor in the patient's sample, but, this could not be confirmed as the sample was not available to complete the investigation.

Manufacturer Narrative

The sample was submitted for investigation.Investigation confirmed the presence of a ruthenium interfering factor.This specific interference is addressed in product labeling.

• 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: 5191741
• MDR Text Key: 30421513
• Report Number: 1823260-2015-04417
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup,Followup,Followup
• Report Date: 12/17/2015

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: 186893
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 10/07/2015
• Initial Date FDA Received: 10/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/02/2015; 11/17/2015; 12/17/2015
• 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
• Patient Age: 062 YR