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

Model Number 08H67-03

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

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 a burning smell coming from the cell-dyn ruby after trying to perform a restart when the instrument stopped working.The field service representative (fsr) performed troubleshooting and observed multiple components on the pdm board were charred and melted.No injuries or harm were reported.

Manufacturer Narrative

The field service representative (fsr) performed troubleshooting and observed multiple components on the pdm board (power distribution module) were charred and melted.The damaged pdm board, part number 9601981 was replaced and the instrument returned to normal working conditions.Based on the complaint text and photos provided, the smoke/burned area was contained.The pdm is made from nema grade fr-4 material, which is a flame-retardant material.Also, the pdm is completely enclosed inside the cell-dyn ruby metal chassis with no customer access.Further investigation of the customer issue included review of submitted data, product historical data, and product labeling.A review of historical data did not find a product issue related to the complaint incident.A review of tracking and trending did not identify any trends for the complaint issue.Labelling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the power distribution pcb assy or the cell-dyn ruby, serial (b)(6) 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: 10178201
• MDR Text Key: 195892406
• Report Number: 2919069-2020-00026
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740099916
• UDI-Public: 00380740099916
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08H67-03
• Device Catalogue Number: 08H67-03
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1