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

Catalog Number 08H67-01

Device Problem Explosion (4006)

Patient Problem No Patient Involvement (2645)

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A followup report will be submitted when the evaluation is complete.Evaluation in process.

Event Description

The account stated the cell-dyn ruby analyzer had an explosion with soot on the top of the analyzer and monitor.The cell-dyn ruby analyzer is off but the monitor is on with a message of serious error code 2077.The power switch was then turned off on the cell-dyn ruby analyzer and the monitor.No patient involved.No injury or exposure was reported.

Manufacturer Narrative

The investigation consisted of review of the complaint text, product historical data, product labeling, and consultation with on-market engineering.Review of product historical data for any trends and all customer complaints received for this issue did not identify any adverse trends or abnormal complaint activity.The power supply is not available for return for investigation, since the unit was discarded.The service engineer stated that the power supply unit replaced did not present any residues or traces of explosion, or flames.A review of the product labeling concluded that the issue is sufficiently addressed.No product deficiency was identified.

• 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: 7818297
• MDR Text Key: 118750823
• Report Number: 2919069-2018-00042
• 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: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• 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: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1