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	06/02/2025
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.Complete information for section a1 patient identifier is sid (b)(6).
Event or Problem Description
The customer observed a falsely depressed hemoglobin cell-dyn ruby results for one patient.The result was higher when repeated on the same instrument.The following data was provided: ruby serial number (b)(6), sid (b)(6), processed on (b)(6) 2025: results from 7:54 am: hemoglobin = 7.12 g/dl.Other results: rbc = 206 10e4/ul, mcv = 106, wbc = 95.5 10e2/ul, plt = 27.4 10e4/ul.Results from 8:45 am new sample same patient: hemoglobin = 8.90 g/dl.Other results: rbc = 260, mcv = 107, wbc = 84.6, plt = 23.3.Results from 9:37 am new sample same patient: hemoglobin = 9.60 g/dl.Other results: rbc = 283, mcv = 105, wbc = 71.7, plt = 22.1 there was no impact to patient management reported.
Additional Manufacturer Narrative
The customer reported a discrepant hgb result generated on the cell dyne ruby instrument (list number 08h67-01), serial number (b)(6).A definitive part was not identified as likely cause for the issue; therefore, the cell dyne ruby instrument serial number (b)(6) was deemed the likely cause.The module function was verified with a control/precision run.The service history of the cell dyne ruby instrument (list number 08h67-01), serial number (b)(6) returned no additional complaint tickets for the module generating discrepant hgb patient results.A review of all complaints associated and a review of complaint trends for the list number was performed.The review did not identify any increased complaint activity.Additionally, labeling was reviewed and adequately addressed the issue under review.Based on the investigation, no systemic issue or deficiency of the cell dyne ruby instrument (list number 08h67-01) serial number (b)(6) was identified.
Event or Problem Description
The customer observed a falsely depressed hemoglobin cell-dyn ruby results for one patient.The result was higher when repeated on the same instrument.The following data was provided: ruby serial number (b)(6), sid (b)(6), processed on (b)(6) 2025: results from 7:54 am: hemoglobin = 7.12 g/dl.Other results: rbc = 206 10e4/ul, mcv = 106, wbc = 95.5 10e2/ul, plt = 27.4 10e4/ul.Results from 8:45 am new sample same patient: hemoglobin = 8.90 g/dl.Other results: rbc = 260, mcv = 107, wbc = 84.6, plt = 23.3.Results from 9:37 am new sample same patient: hemoglobin = 9.60 g/dl other results: rbc = 283, mcv = 105, wbc = 71.7, plt = 22.1 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: 22212672
• Report Number: 2919069-2025-00024
• Device Sequence Number: 8132650
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: (01)00380740017170
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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: 06/02/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2016
• 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