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 Consequences Or Impact To Patient (2199)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported observing visible smoke and a burning smell from the cell dyn ruby analyzer.There was no impact to patient management, user safety, or facility damage reported.
Additional Manufacturer Narrative
The investigation consisted of a review of product historical data, product labeling, and consultation with on-market engineering.A review of customer complaints did not identify any other complaints or trends for this issue.The returned fan assemblies (3 fans) had their coil resistance measured using a calibrated fluke 87 digital multimeter and 2 out of the 3 fans were out of specification.The damage stated in the complaint could be the cause of the out of specification fans.The reported smoke coming from the 3 fans of the cell-dyn ruby analyzer may have been caused by accumulation of dust rubbing on the ball bearing inside the fan, which in turn caused excessive coil current overheating, damaging the fans.The cell-dyn ruby operator's manual was reviewed and provides adequate information related to this incident.Based on the investigation no product deficiency was identified for cell-dyn ruby, serial number (b)(4) or the 3 fan assemblies (part number 8921213001).

• 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: 7141713
• Report Number: 2919069-2017-00169
• Device Sequence Number: 1108967
• Product Code: GKZ
• UDI-Device Identifier: 00380740099916
• UDI-Public: 00380740099916
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 03/29/2018

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?: No
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1