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

Model Number 08H67-01

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported the failure of a cell dyn ruby after repeated power outages associated with a storm and lightening.The customer stated fire/visible smoke was observed from the instrument.There was no report of injury.There was no reported impact to patient management.

Manufacturer Narrative

A subsequent site visit by the field service engineer (fse) for analyzer (sn#: (b)(6)occurred post repeated power outages associated with an electrical storm.The motor board and the accessories peripheral ports were replaced by the fse which resolved the issue.A review of the service history for the cell-dyn ruby analyzer revealed no additional issues were reported.A review of tracking and trending did not identify any trends for the cell-dyn ruby.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Labeling was reviewed and contains adequate information on troubleshooting, removal and installation of the part.The evidence of fire was limited to the board and the peripheral ports and did not spread to other parts of the instrument.Based on the investigation, no product deficiency was identified.

Event Description

The customer reported the failure of a cell dyn ruby after repeated power outages associated with a storm and lightening.The customer stated fire/visible smoke was observed from the instrument.There was no report of injury.There was no reported impact to patient management.

• 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: 10564387
• MDR Text Key: 207878770
• Report Number: 2919069-2020-00033
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08H67-01
• Device Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1