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

Catalog Number 06437281190

Device Problem High Test Results (2457)

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

Event Date 10/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer complained of erroneous results for 1 patient tested for elecsys ft4 ii assay (ft4 ii) on a cobas 6000 e 601 module compared to a cobas e 801 module.The initial ft4 ii result from the e601 module was >100 pmol/l.This result was reported outside of the laboratory where the physician did not trust the result as the patient had no record of thyroidism and the tsh was within the normal range.The sample was repeated on an e 801 module and the result was 23.8 pmol/l.The patient¿s tsh result on both the e601 module and the e801 module was 0.43 mu/l.There was no allegation that an adverse event occurred.The serial numbers for the e601 module and the e801 module were not provided.A specific root cause was not identified.Additional information was requested for investigation but was not provided.The different results from different analyzers may have been caused by the presence of a possible assay interfering factor.This interfering factor could affect the results for the ft4 ii assay due to physical setups of the assay on each analyzer.Based on the information available, a general reagent issue could be excluded.There was not enough sample volume left to complete the investigation; therefore it was not possible to determine the root cause of the different ft4 ii results between the two analyzers.

• 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: 7012784
• MDR Text Key: 92609199
• Report Number: 1823260-2017-02562
• 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,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/09/2017

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
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/09/2017
• 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: 46 YR