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 04/20/2015

Event Type  malfunction  

Event Description

The customer observed smoke coming from the right side panel of the tdxflx analyzer.The customer indicated they were attempting to run a calibration at the time.They unplugged the analyzer upon seeing the smoke.There was no injury to the instrument operator or impact to patient management reported.

Manufacturer Narrative

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

Manufacturer Narrative

Further evaluation of the customer issue included a review of the complaint text, review of the analyzer by abbott field service, review of service history, a search for similar complaints, and a review of labeling.A photo of the reagent display board was provided and reviewed.The abbott field service engineer (fse) identified a burnt component on the reagent display board and replaced the board.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 smoking for the reagent display board 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, are provided.Based on the available information no product deficiency of the tdxflx, list number 04a24, 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: 4771638
• MDR Text Key: 18890923
• Report Number: 1628664-2015-00157
• 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: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• 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: 05/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/1993
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1