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

Catalog Number 04A24-96

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) review by the abbott field service engineer (fse) identified the source of the smoke as a dirty air heater assembly.A clogged fan with gasket was also replaced to return the analyzer to normal function.The observed damage was limited to the air heater assembly and did not spread to other parts of the analyzer.Further evaluation of the customer issue included a review of the complaint text, a search for similar complaints, and a review of labeling.Return parts were not available.Review of the service history, for instrument serial number (b)(4), did not identify any other issues that may have contributed to the current complaint issue.A tracking and trending review was completed; no adverse trend for smoke/burn complaints of the fan with gasket was identified.Labeling was reviewed and it was determined that adequate instructions, as to the specific requirements for safe and optimum performance of the system, which includes leaving the instrument power on continuously and allowing for adequate ventilation.Instructions for performing an emergency shutdown are also provided.Based on the available information no product deficiency air heater assembly of the tdxflx, list number 04a24, was identified.

Event Description

The customer observed smoke while using the tdxflx analyzer.The customer indicated that when turned the analyzer back on, after cleaning the air filter, a puff of smoke was visible and inside the carousel was warm.No injuries or impact to patient management were reported.

• 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: 5541570
• MDR Text Key: 41920729
• Report Number: 1628664-2016-00084
• 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
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• 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: 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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