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

Catalog Number ASKU

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for one patient sample tested for elecsys ft3 iii (ft3) and the elecsys ft4 ii assay (ft4) on a cobas 8000 e 602 module (e602).No erroneous results were reported outside of the laboratory.The date of event was asked for, but is not known.A clarification of the correct date has been requested.This medwatch will apply to the ft4 assay.Please refer to the medwatch with (b)(6) for information concerning the ft3 assay.The sample was initially tested only for ft3 at the customer site on an e602 analyzer.The sample was then provided for investigation, where it was tested on another e602 analyzer and a cobas e 411 immunoassay analyzer (e411).No adverse events were alleged to have occurred with the patient.The serial number of the e602 analyzer used at the customer site was asked for, but not provided.The e602 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 265631, with an expiration date of september 2018 was used on this analyzer.The e411 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 265631, with an expiration date of september 2018 was used on this analyzer.

Manufacturer Narrative

The date of event has been confirmed as (b)(6) 2017.Medwatch field has been updated.For investigation, the sample was measured on the e411 analyzer on (b)(6) 2017 and on the e602 analyzer on (b)(6) 2017.The patient sample was provided for further investigation.The ft3 and ft4 values generated by the customer and during initial investigations could be duplicated.Further investigations of the sample detected an interfering factor which interferes with a component of the ft3 and ft4 assays.This limitation is covered in product labeling.

• 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: 7052454
• MDR Text Key: 93568118
• Report Number: 1823260-2017-02730
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

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: 09/30/2018
• Device Catalogue Number: ASKU
• Device Lot Number: 265631
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2017
• Initial Date FDA Received: 11/22/2017
• Supplement Dates Manufacturer Received: 11/02/2017
• Supplement Dates FDA Received: 12/13/2017
• 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: 58 YR