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

Catalog Number	08H67-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final 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 falsely decreased cbc results generated on the cell-dyn ruby analyzer for patient samples.The following data was provided: patient 2 platelet result = 6.0, slide review result = 150 (normal) no impact to patient management was reported.
Event or Problem Description
The customer observed falsely decreased cbc results generated on the cell-dyn ruby analyzer for patient samples.The following data was provided: patient 2 platelet result = 6.0, slide review result = 150 (normal).No impact to patient management was reported.
Additional Manufacturer Narrative
Additional information in section h4 - device mfg date.The complaint investigation included a search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.Review of the service history report did not show any sign of additional problems occurring on the instrument.A search for similar complaints did not identify an increase in complaint activity.A review of tracking and trending did not identify any trends for the issue for the product.Labeling was reviewed and found to adequately address the issue under review.Based on our investigation, no systemic issue or deficiency with the cell-dyn ruby for serial number 72037bg or the peristaltic pump tubing, 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 N39 E-932 ; GM N39 E932 ; 6122582960
• MDR Report Key: 18715227
• Report Number: 2919069-2024-00018
• Device Sequence Number: 14834018
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: (01)00380740017170
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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: 01/29/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2021
• 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