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

Catalog Number 04A24-01

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 11/09/2016

Event Type  malfunction  

Manufacturer Narrative

An abbott field service engineer (fse) arrived at the customer site to inspect the abbott tdx/flx analyzer.The fse found no evidence of any burning of the reagent display door or associated printed circuit board.The fse proceeded to replace the suspect hardware.Subsequent instrument operations were acceptable.A review of the service history of the analyzer did not identify any issues that may have contributed to the current customer issue.A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation.The tdxflx system operations manual contains information to address the current customer issue.Based on the available information from the customer site and from the results of this evaluation, there is evidence to reasonably suggest a product malfunction occurred.A product deficiency is not indicated.

Event Description

The customer called to report that the display keypad of the abbott tdx/flx analyzer began to feel hot to the touch and then starting smoking.No visible flames were observed.The issue was confined to the analyzer.No injuries or damage to the surrounding lab environment were reported.The customer powered off and unplugged the analyzer from the electrical outlet.A service call was initiated.

• 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: 6115891
• MDR Text Key: 60423585
• Report Number: 1628664-2016-00287
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 11/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04A24-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/1991
• 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: DOOR, REAGENT DISPLAY WITH BOARD; LN: 3-45036-01