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

Catalog Number	08H67-03
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed erratic hemoglobin results on the cell dyn ruby analyzer for one patient.The following results were generated (reference range 13.5 - 16.5 g/dl): initial hemoglobin result= 7.5 g/dl; repeat result= 8.9 g/dl.Updated information was provided on 21may2025.Patient was a 67-year-old female.Samples testing was performed on (b)(6) 2025, sid: (b)(6).The following additional results were provided: initial wbc result= 11.8 10e3/ul; repeat result= 11.5 10e3/ul.Initial neutrophil result= 9.35 10e3/ul; repeat result= 9.10 10e3/ul.Initial hemoglobin result= 7.50 g/dl; repeat result= 8.59 g/dl.Initial platelet result=234 10e3/ul; repeat result= 232 10e3/ul.There was no impact to patient management reported.
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.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the cell-dyn ruby analyzer serial number (b)(6) and multiple parts were cleaned; however, a definitive part was not identified as the issue.The service history of the cell-dyn ruby analyzer serial number (b)(6) returned no additional complaint tickets for the module generating discrepant hemoglobin patient results.A review of tracking and trending of the cell-dyn ruby analyzer did not identify any trends 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 adequately addressed the issue under review.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 erratic hemoglobin results on the cell dyn ruby analyzer for one patient.The following results were generated (reference range 13.5 - 16.5 g/dl): initial hemoglobin result= 7.5 g/dl; repeat result= 8.9 g/dl.Updated information was provided on 21may2025.Patient was a 67-year-old female.Samples testing was performed on (b)(6) 2025, sid (b)(6).The following additional results were provided: initial wbc result= 11.8 10e3/ul; repeat result= 11.5 10e3/ul.Initial neutrophil result= 9.35 10e3/ul; repeat result= 9.10 10e3/ul.Initial hemoglobin result= 7.50 g/dl; repeat result= 8.59 g/dl.Initial platelet result=234 10e3/ul; repeat result= 232 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: 22095576
• Report Number: 2919069-2025-00020
• Device Sequence Number: 12777547
• Product Code: GKZ
• UDI-Device Identifier: 00380740099916
• UDI-Public: (01)00380740099916
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 06/27/2025

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: 08H67-03
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2014
• 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 Age: 67 YR
• Patient Sex: Female