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

Catalog Number 06437281160

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 01/31/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) #: asku.The event occurred in (b)(6).

Event Description

The customer asked for an investigation of a patient sample for thyroid tests performed on a cobas 8000 e 602 module with unknown serial number.Refer to the attachment to this report for all data.The initial test results were reported outside the laboratory.This report is for the ft4 reagent.Refer to the report with (b)(6) for the ft3 reagent.There was no allegation of an adverse event.Insufficient sample was available for further investigation.The differences in results between the e602 and e601 modules and the e411 analyzer may be due to a biological interferent present in the sample.Without additional sample material to investigate, it is not possible to test this possibility.

• Brand Name: ELECSYS FT4
• 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: 6336995
• MDR Text Key: 67663328
• Report Number: 1823260-2017-00355
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: ASKU
• 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: 02/16/2017

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: 06437281160
• Device Lot Number: ASKU
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2017
• Initial Date FDA Received: 02/16/2017
• 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