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

Catalog Number 06437281190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer initially questioned results for 1 patient tested for elecsys ft3 iii (ft3 iii) and elecsys ft4 ii assay (ft4 ii) on a cobas 8000 e 602 module.The sample was sent to an external laboratory to run the same tests on a competitor system.Only the ft3 iii result from the competitor system was provided.Based on the data provided, erroneous ft3 iii results were identified.The erroneous results were reported outside of the laboratory.These erroneous ft3 iii results for the patient were previously reported on manufacturer report 1823260-2017-00057-00.Additional information on the ft3 results will be sent as a supplemental to that report.The customer provided comparison results for ft4 ii on (b)(6) 2017.Based on the data provided, erroneous ft4 ii results were identified when the customer performed repeat testing on the e602 module.This report will cover the erroneous ft4 ii results provided on (b)(6) 2017.On (b)(6) 2016 the initial ft4 ii result was 0.135 ng/dl.The repeat result was 0.182 ng/dl.On (b)(6) 2016 the initial ft4 ii result was 0.148 ng/dl.The repeat result was 0.050 ng/dl.No adverse event occurred.The e602 module serial number was (b)(4).The measuring cells on the instrument were changed about 2 months ago.

Manufacturer Narrative

A specific root cause could not be identified.Additional information was requested for investigation but was not provided.The calibration signals provided by the customer for ft3 iii and ft4 ii were on the low side but acceptable.Quality control (qc) results for both ft3 iii and ft4 ii were within the specifications.Based on the information provided, no pre-analytical issues were identified.Since calibration and qc were acceptable, a general reagent issue at the customer site can most likely be excluded.An interference may have been present, however, this cannot be confirmed since a patient sample could not be provided.

• 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: 6283820
• MDR Text Key: 66010826
• Report Number: 1823260-2017-00179
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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,Followup
• Report Date: 02/14/2017

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: 15822300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 01/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/14/2017
• 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
• Treatment: AMOKSISILIN; CABERGOLINE - 2X A WEEK; LANSOPRAZOL - 1X A DAY; LEVOTIROKSIN SODIUM - 1X A DAY