MAUDE Adverse Event Report: ABBOTT LABORATORIES CELL-DYN SAPPHIRE SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number 08H00-03

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/03/2022

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 account observed smoke coming from the back of the cell-dyn sapphire.The account stated after a strange sound from the left backside of the analyzer, smoke was seen and a strange odor.The account unplugged the power cord.The account technical service confirmed nothing was wrong with the wall socket or power at the account.No specific patient information provided as there was no patient involvement.No injury was reported.

Manufacturer Narrative

The likely cause part was the motion control power supply (mcps).The mcps part was replaced and qc recovered within specifications.A similar complaint review was performed showing no increase in complaint activity.A ticket trending review was performed showing no increase in complaint activity.No adverse trends were identified based upon the likely cause.No issues identified when reviewing corrective and preventative actions and non-conformances for the likely cause.The investigation included a review of product historical data, and product labeling.Review of historical data did not find a product issue related to the complaint incident.Labeling was found to be adequate for the complaint issue.No product deficiency was identified.

• Brand Name: CELL-DYN SAPPHIRE SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer (Section G): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15029408
• MDR Text Key: 304509106
• Report Number: 2919069-2022-00020
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740016623
• UDI-Public: 00380740016623
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K051215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

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
• Device Operator: Health Professional
• Device Model Number: 08H00-03
• Device Catalogue Number: 08H00-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2022
• Initial Date FDA Received: 07/15/2022
• Supplement Dates Manufacturer Received: 08/22/2022
• Supplement Dates FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1