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

Catalog Number 06437281190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The customer stated that they have seen several spurious thyroid function results.The customer provided data for five patient samples for which the elecsys thyrotropin (tsh) results do not match the free triiodothyronine (ft3) results, free thyroxine (ft4) results, or the patients' clinical picture.It was stated that the samples were all repeated on the architect analyzer where it has been confirmed that the ft3, ft4, and tsh are all normal.All patients received high doses of biotin as part of treatment for multiple sclerosis.The pathologist commented that the biotin treatment mimics the complete hyperthyroid picture with no discrepancy of results.The pathologist also commented that they previously had issued of false high ft4 results due to thyroxine ingestion or "non-specific igm interference".No other data was provided with regards to the pathologist's comments.The customer provided the data seen in the attachment.Each date represents a different sample from the patient.The complained samples are highlighted in yellow.There were erroneous elecsys tsh, ft3, and ft4 results for all samples.This medwatch will cover ft4.Please refer to the medwatch with (b)(6) for information related to tsh and to the medwatch with (b)(6) for information related to ft3.It was stated that one of the five patients was scheduled for a thyroidectomy based on the elecsys results, but the surgery was cancelled after the pathologist determined that there was a discrepancy in the results.The patients were not adversely affected.It was asked, but it is not known what analyzer model or serial number was used for testing with the elecsys ft3, ft4, and tsh assays.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.A sample from the patient was requested for investigation, but could not be provided.A general reagent issue could not be detected.

• 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: 5654632
• MDR Text Key: 45199444
• Report Number: 1823260-2016-00636
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

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: 06437281190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2016
• Initial Date FDA Received: 05/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2016
• 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