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

Catalog Number	08H67-03
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed smoke coming from the back of the cell-dyn ruby analyzer and also observed a burning odor while the analyzer was turned on but was not being used.Then the laboratory circuit breaker blew.The circuit breaker could not be restored until the analyzer was turned off.No fire or injury were reported.
Additional Manufacturer Narrative
An abbott field service engineer was dispatched to the account and found the cell-dyn ruby analyzer power supply assembly (part 8934104701) was the source of the smoke.Burnt lint was found inside and outside of the power supply.The smoke from the analyzer was limited to this part and did not spread to other parts of the equipment.The power supply (power supply, spec, lambda, custom, cdruby part 8934104701) 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, investigation of the returned power supply, and a review of labeling.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.The issue was resolved through standard troubleshooting procedures.The returned power supply was found to be inoperative.Burnt lint was found inside and outside the part.The probable cause of the smoke may be related to the excessive lint found inside the unit.Filters on the fan may not have been cleaned properly during maintenance, contributing to the buildup of lint within the unit.Lint accumulated inside the unit may limit the fan air flow capacity to remove heat from the unit.Based on all available information and abbott diagnostics complaint investigation for the cell-dyn ruby analyzer, no systemic issue and no product deficiency was identified.

• Brand Name: CELL-DYN RUBY ANALYZER
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 6642163
• Report Number: 2919069-2017-00098
• Device Sequence Number: 925992
• Product Code: GKZ
• UDI-Device Identifier: 00380740099916
• UDI-Public: 00380740099916
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K061667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 08H67-03
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 07/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1