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

Catalog Number	08H67-01
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated that the power cable on the cell dyn ruby analyzer suddenly caught fire.The power cord and the celeron computer assembly were replaced.There was no visible damage to the instrument, lab and to any personnel.No report of injuries/exposure or impact to user safety and no impact to analytical patient results.
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 stated that the power cable on the cell dyn ruby analyzer suddenly caught fire.The power cord and the celeron computer assembly were replaced.There was no visible damage to the instrument, lab and to any personnel.No report of injuries/exposure or impact to user safety and no impact to analytical patient results.Update: the burning of cord was caused by the splashing of liquid waste from loose liquid waste tubing.The loose waste tubing was immediately fixed and the burnt power cord was replaced using a non-abbott power cord.The cable that burned was a non-abbott cable and was replaced with another non-abbott cable.
Additional Manufacturer Narrative
Additional information added to b5.The cell-dyn ruby, serial number: (b)(6) was evaluated.The distributor service representative indicated a loose waste tubing from the analyzer splashed liquid onto the power cord, which caused the power cord to burn.The customer was using a non-abbott power cord.As the instrument is owned by a dealer, the dealer replaced the power cord and the instrument was returned to normal operation after the part was replaced.A review of the instrument service history was performed and found no contributing factor on or around the date of the event.There have been no further documented occurrences of fire or burnt components after on-site servicing was performed.A complaint search was performed and no additional complaints were identified associated with this issue of a loose and leaking/splashing waste tubing, tubing, tygon,.125 inch id,.250 inch od, r-3603, blk stripe, contributing to a smoke/fire/burning incident.A review of tracking and trending did not identify any trends involving replacements of the tubing, tygon,.125 inch id,.250 inch od, r-3603, blk stripe.Manufacturing documentation was reviewed and did not identify any non-conformance's associated with the complaint issue.Additionally, labeling was reviewed and was found to adequately address the customer issue.Based on the investigation, no systemic issue or deficiency was identified.

• Brand Name: CELL-DYN RUBY SYSTEM
• Common Device Name: 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 20280034
• Report Number: 2919069-2024-00054
• Device Sequence Number: 12626050
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: (01)00380740017170
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K061667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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 Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown