MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN RUBY ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number 08H67-01

Device Problems Charred (1086); Overheating of Device (1437); Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer saw and smelled smoke in the back of the cell-dyn ruby analyzer and the power supply did not start up.An abbott field service engineer found a damaged power distribution (pdm) board on the analyzer.No injury or fire were reported.

Manufacturer Narrative

An abbott field service engineer was dispatched to the account and found a damaged power distribution (pdm) board [part 8960310001], the affected board showed burn marks.The smoke from the analyzer was limited to this part and did not spread to other parts of the equipment.The power distribution (pdm) board [part 8960310001] was replaced.The analyzer was returned to normal operation.Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, instrument service review, and returned part examination.No adverse trend was identified for the customer issue.Product labeling was reviewed and found to be adequate, as it contains instructions regarding electrical specifications and requirements, electrical hazards, and of electrical safety for the cell-dyn ruby analyzer.Analyzer service history was reviewed and no contributing factors were found.No subsequent reports of smoke/burn issues were identified.Returned part examination of power distribution (pdm) board [part 8960310001] found a charred 28v power trace on the back of the board.The charring may have been caused by an overcurrent in the 28v input power line.The charring appeared to be the result of excessive heat dissipation due to the overcurrent.However, the exact cause of the damage was unknown.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

• Brand Name: CELL-DYN RUBY ANALYZER
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 7374808
• MDR Text Key: 103946189
• Report Number: 2919069-2018-00022
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• PMA/PMN Number: K061667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1