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

Catalog Number 08H67-01.

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

An abbott representative observed smoke on the shm plate during troubleshooting on the cell dyn ruby analyzer.No additional damage was reported.No injuries or harm was reported.

Event Description

An abbott representative observed smoke on the shm plate during troubleshooting on the cell dyn ruby analyzer.No additional damage was reported.No injuries or harm was reported.

Manufacturer Narrative

An evaluation is still in process.A follow-up report will be submitted when the evaluation is complete.After further evaluation, section d4: catalog no was updated from 08h67-10 to 08h67-01.H3 other text: device evaluation is in process.

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 the pcb assy-shm-rohs, and assy-sol-24vdc-cd3200ii-rohs did not identify any trends abnormal complaint activity.Labeling was reviewed and found to be adequate.For this hazard source, ha 831, a method of control listed is the use covers, and a control verification listed is that system is built to safety standards such as iec 61010-1, ul 61010a-1.The overheated area at the shm was contained.In addition, the shm is located inside the chassis of the cell-dyn ruby analyzer and cannot be accessed by the customer.Based on the investigation, no systemic issue or deficiency of the pcb assy-shm-rohs, assy-sol-24vdc-cd3200ii-rohs, or the cell-dyn ruby, serial (b)(6) was identified.After further evaluation, section d4: catalog no was updated from 08h67-01 back to 08h67-10.

Manufacturer Narrative

This follow-up is being submitted to correct data in field d4 catalog no (from 08h67-10.To 08h67-01.).

• Brand Name: CELL-DYN RUBY SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 11064876
• MDR Text Key: 223398046
• Report Number: 2919069-2020-00040
• Device Sequence Number: 1
• Product Code: GKZ
• 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,Followup,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1