MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC TDXFLX SYSTEM; AUTOMATED FLUORESCENT IMMUNOASSAY ANALYZER

Catalog Number 04A24-96

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 03/11/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.

Event Description

The customer observed visible smoke while using the tdx analyzer.The customer reported visible smoke from right hand side of instrument and the display/keypad was hot to the touch.No visible flame or sparks were observed.The customer has turned system off and unplugged it.There was no injuries reported and no impact to patient management.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and instrument service.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The tdxflx system operations manual contains information on operational precautions and limitations, and directions for emergency shutdown of the tdx/flx analyzer.The tdx/tdxflx service manual addresses the removal and replacement of the reagent display door with board.The reagent display door with board (part number 3-45036-01) was replaced.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: TDXFLX SYSTEM
• Type of Device: AUTOMATED FLUORESCENT IMMUNOASSAY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6439874
• MDR Text Key: 71051444
• Report Number: 1628664-2017-00082
• Device Sequence Number: 1
• Product Code: JJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04A24-96
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/1993
• 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