MAUDE Adverse Event Report: ABBOTT LABORATORIES CELL-DYN RUBY; 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	04/03/2025
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 a falsely depressed wbc on the cell dyn ruby analyzer for one patient that was not reported out of the laboratory.The customer reported that the cell dyn analyzer would generate low results for all analytes, but when the sample was repeated the results were higher.The following results were provided (reference range wbc 6.1 ¿ 7.6 10e3/ul): initial wbc result= 0.64 10e3/ul; repeat result= 8.16 10e3/ul.There was no impact to patient management reported.
Additional Manufacturer Narrative
Update date to section b3 - date of event, correction of date from 03mar2025 to 03apr2025.The cell-dyn ruby analyzer, serial number (b)(6), was considered the likely cause of the result issue as a single definitive part could not be determined and no troubleshooting was performed.Return testing was not completed as returns were not available.The instrument service history for the (b)(6) found no additional complaints of discrepant low results reported after the current event was identified.A review of tracking and trending of the cell-dyn ruby analyzer did not identify an increase in complaint activity associated with the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the cell-dyn ruby analyzer, serial number (b)(6) was identified.
Event or Problem Description
The customer observed a falsely depressed wbc on the cell dyn ruby analyzer for one patient that was not reported out of the laboratory.The customer reported that the cell dyn analyzer would generate low results for all analytes, but when the sample was repeated the results were higher.The following results were provided (reference range wbc 6.1 ¿ 7.6 10e3/ul): initial wbc result= 0.64 10e3/ul; repeat result= 8.16 10e3/ul.There was no impact to patient management reported.

• Brand Name: CELL-DYN RUBY
• 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: 21881318
• Report Number: 2919069-2025-00016
• Device Sequence Number: 15395068
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: (01)00380740017170
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/28/2025

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): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• 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