MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 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 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer questioned thyroid results for 1 patient and submitted the sample for investigation.Based on the data provided, erroneous results were identified for elecsys ft3 iii (ft3 iii) and ft4 between the customer¿s cobas 8000 e 602 module and a cobas 6000 e 601 module used at the investigation site and a cobas e 411 immunoassay analyzer used at the investigation site.The customer¿s initial results were reported outside of the laboratory.This medwatch will cover ft4.Refer to medwatch with a1 patient identifier (b)(6) for information on the ft3 iii erroneous results.Refer to the attached data for patient results.There was no allegation that an adverse event occurred.The e601 analyzer serial number was (b)(4).The e411 analyzer serial number was (b)(4).The ft4 ii reagent lot number used at the investigation site was 185414 with an expiration date of 11/30/2017.The serial number for the customer's e602 analyzer is not known.

Manufacturer Narrative

Further investigation of the patient sample confirmed the customer's ft3 iii and ft4 results.Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed.This most likely caused the high ft4 and ft3 iii results.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.The incidence rate of the identified interfering factor is monitored on a quarterly basis.

• Brand Name: ELECSYS FT4 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: 6630728
• MDR Text Key: 77520881
• Report Number: 1823260-2017-01194
• 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,Followup
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2017
• 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