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 03/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up will be submitted when the evaluation is complete.

Event Description

The customer stated that they observed smoke coming from the right side of the tdx/tdxflx instrument behind the display panel when they were running a calibration.There was no visible damage or fire seen.The customer powered the unit off and unplugged.There was no reported injury or impact to user safety and no impact to analytical patient results.

Manufacturer Narrative

Smoke was observed coming from tdxflx, serial number (b)(4), during assay calibration.The customer powered off and unplugged the analyzer.The field service engineer (fse) identified several damaged resistors on the reagent display door with board (part number 3-45036-01) and replaced the part.The fse verified the system to be functional again after replacement of the reagent display door with board.A return was not available but the fse provided two file images that confirm the damage on the part.A review of the service history did not identify any issues that may have contributed to the current complaint.The tdx/flx system operations manual contains adequate information on operational precautions and limitations of the analyzer.A review of the 2016 ul certification memo found adequate information noting abbott diagnostic equipment and accessories are certified to the appropriate safety standards, and adequate protection is provided for the operator against spread of fire from the equipment.A review of history for the reagent display door with board (part number 3-45036-01) found no trends.Based on this investigation no systemic deficiency or malfunction was identified for the reagent display door with board (part number 3-45036-01).

Manufacturer Narrative

The device evaluation was reassessed and concluded that a malfunction occurred, therefore the device was not performing as intended.

• 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: 5588460
• MDR Text Key: 43479279
• Report Number: 1628664-2016-00103
• 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,Followup
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• 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: 04/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/1992
• 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