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 06/25/2015

Event Type  malfunction  

Event Description

The customer complained of erroneous results for 1 patient sample tested for free thyroxine (ft4).Based on the data provided, erroneous thyrotropin (tsh) results were also identified.The customer was comparing results between a cobas e601 analyzer and an auto delfia analyzer.One tube of serum and one tube of plasma were obtained from the patient from the same blood draw.The results from the e601 analyzer were produced from the tube of plasma and the results from the auto delfia analyzer were produced from the tube of serum.The results were reported outside of the laboratory with a note that the ft4 results from the e601 analyzer were "unlikely." the results from the auto delfia analyzer were considered to be correct.This medwatch will cover ft4.Refer to medwatch with patient identifier (b)(6) for information on the tsh erroneous results.The initial ft4 result was 93.9 pmol/l.On (b)(6) 2015, the sample was repeated on the e601 analyzer and the result was 82.8 pmol/l.The repeat result from the auto delfia analyzer was 18.4 (unit of measure not provided).The initial tsh result was 0.3 mu/l.On (b)(6) 2015, the sample was repeated on the e601 analyzer and the result was 0.25 mu/l.The repeat result from the auto delfia analyzer was 1.0 mu/l.No adverse event occurred.No medical decisions were made based on the e601 results.The cobas e601 analyzer serial number was (b)(4).

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

The sample was sent in for investigation.Investigation confirmed the presence of a streptavidin 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) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4925505
• MDR Text Key: 6031200
• Report Number: 1823260-2015-03821
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 08/04/2015

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: 07/02/2015
• Initial Date FDA Received: 07/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2015
• 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
• Patient Sequence Number: 1
• Patient Age: 053 YR