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

Catalog Number 06437281160

Device Problem High Test Results (2457)

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

Event Date 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of discrepant results for elecsys tsh assay (tsh) and elecsys ft4 assay (ft4) when comparing results from two cobas 8000 e 602 modules (e602) to other systems for one patient sample.This medwatch will apply to the ft4 assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the tsh assay.Refer to the attachment for all patient data.The initial ft4 results were not reported outside of the laboratory.The customer determined the repeat result from the centaur system was correct.There is no allegation of adverse event.The initial sample was aliquoted by a modular pre-analytics system.The serial number of (b)(4) was provided but unable to determine which of the e602s it applies to.Clarification was requested but not provided.The customer believes the patient sample may contain an interference against the test.Investigation is still ongoing.

Manufacturer Narrative

The patient sample was submitted for investigation.The tsh and ft4 values generated at the customer site were confirmed.An interfering factor was found in the sample.Interferences are documented in product labeling for the assay.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.

• Brand Name: ELECSYS FT4 II ASSAY
• 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: 6903708
• MDR Text Key: 89494185
• Report Number: 1823260-2017-02150
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2017

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 Expiration Date: 03/31/2018
• Device Catalogue Number: 06437281160
• Device Lot Number: 21546100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2017
• Initial Date FDA Received: 09/29/2017
• Supplement Dates Manufacturer Received: 09/11/2017
• Supplement Dates FDA Received: 10/31/2017
• 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: 73 YR