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 Type  malfunction  

Event Description

The customer reported a burnt smell accompanied by visible smoke coming from the abbott tdxflx analyzer.No injuries were reported nor any damage to the surrounding laboratory environment.The power to the analyzer was terminated and the power cord pulled from the wall outlet.There was no impact to patient management reported.

Manufacturer Narrative

(b)(4).The customer observed smoke from around the specimen carousel loading position of the tdx/flx analyzer.No fire was observed and nothing was seen to have been burnt.No further action was taken to repair the analyzer as the customer has moved all testing to the architect system.An abbott field service engineer at the customer site verified the customer issue and that the analyzer was unplugged from the power outlet.The tdx/flx analyzer has been removed from the customer site.A return is not required for investigation based on complaint tracking and trending metrics (encompassing 45 months) which found no adverse trends in conjunction with the complaint issue currently under evaluation.The tdx/flx system operations manual provides information to address the current customer issue.A review of the results of this evaluation and information from the customer site reasonably suggests a malfunction occurred, which caused the carousel loading position to smoke.The specific source and cause of the smoke were not identified.A systemic deficiency relating to this issue was not found.

• 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: 4686408
• MDR Text Key: 5636985
• Report Number: 1628664-2015-00133
• Device Sequence Number: 1
• Product Code: JJQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K904226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• 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: 03/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/1992
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1