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

Model Number	08H67-03
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
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 10178201
• Report Number: 2919069-2020-00026
• Device Sequence Number: 17044015
• Product Code: GKZ
• UDI-Device Identifier: 00380740099916
• UDI-Public: 00380740099916
• Combination Product (Y/N): N
• Initial Reporter Country: BU
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2020

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 Model Number: 08H67-03
• Device Catalogue Number: 08H67-03
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1