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

Catalog Number	08H67-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed the waste chambers and vent chamber were full on the cell-dyn ruby analyzer.The customer went to perform a cleaning of waste chamber on the analyzer and a tubing came off causing a spray.The spray from the tubing went onto the ceiling and then dripped from the ceiling onto the top of the customer¿s head.The customer was wearing goggles and a lab coat.The customer washed her hair and had no other treatment.There was no impact to patient management reported.There was no additional harm to the customer reported.
Event or Problem Description
The customer observed the waste chambers and vent chamber were full on the cell-dyn ruby analyzer.The customer went to perform a cleaning of waste chamber on the analyzer and a tubing came off causing a spray.The spray from the tubing went onto the ceiling and then dripped from the ceiling onto the top of the customer¿s head.The customer was wearing goggles and a lab coat.The customer washed her hair and had no other treatment.There was no impact to patient management reported.There was no additional harm to the customer reported.
Additional Manufacturer Narrative
The customer observed the waste chambers and vent chamber were full on the cell-dyn ruby analyzer.The customer went to perform a cleaning of waste chamber on the analyzer and a tubing came off causing a spray.The spray from the tubing went onto the ceiling and then dripped from the ceiling onto the top of the customer¿s head.There were no service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of tracking and trending for the cell-dyn ruby analyzer did not identify any trends.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found no instructions regarding the cleaning of waste chambers.Use error contributed to this event as the labeling does not contain instructions nor does it direct the customer to clean the waste chambers.Based on the investigation the cell-dyn ruby analyzer serial number (b)(6) is performing as intended, no systemic issue or deficiency of the cell-dyn ruby analyzer serial number (b)(6) 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: 19972246
• Report Number: 2919069-2024-00047
• Device Sequence Number: 20978913
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: (01)00380740017170
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/11/2024

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: 08/05/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2016
• 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