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

Catalog Number	08H00-03
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available information was included.Additional details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
During installation after downloading the aos firmware on the cell-dyn sapphire analyzer, upon restarting the instrument there was a burning smell from the machine and visible smoke.The instrument was shut down.On the data station, error 1421 laser current too high.The analyzer was not installed at the customer site.No injuries occurred.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs and a review of labeling.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.A definite cause was not identified, a few factors relating to the laser current, optics bench alignment and/or motion controller power supply could have cause the sim 1421 error.The analyzer was deinstalled.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: CELL-DYN SAPPHIRE ANALYZER
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 8209326
• Report Number: 2919069-2019-00001
• Device Sequence Number: 1670618
• Product Code: GKZ
• UDI-Device Identifier: 00380740016623
• UDI-Public: 00380740016623
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K051215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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: 08H00-03
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1