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

Catalog Number	08H67-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The abbott technician was performing preventative maintenance on the cell dyn ruby analyzer and was splashed in the eye when changing the hemoglobin reagent syringe.The technician was not wearing goggles.She flushed her eyes with water and went to the clinic to get medical care.The technician was given eye drops for treatment (moxifloxacina 0.5% hylo gel eyes drops).There was no reported impact to patient results or patient management.The technician was given eye drops for treatment (moxifloxacina 0.5% hylo gel eyes drops).
Additional Manufacturer Narrative
A field service engineer was performing preventive maintenance on the on the cell dyn ruby analyzer, serial # (b)(6), and was splashed in the eye when changing the hemoglobin reagent syringe 2.5lm while not wearing eyewear/ goggles (personal protective equipment).An instrument service history review for (b)(6) verified no subsequent issues have been reported relating to a splash from a part, after the current issue was identified.A review of tracking and trending did not identify an increase in complaint activity for the hemoglobin reagent syringe 2.5lm.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate for the complaint issue which includes precautions of: wear gloves, lab coats, and protective eye wear when handling human sourced material or contaminated system components.Based on the investigation the cell dyn ruby analyzer and the hemoglobin reagent syringe 2.5lm was performing as intended.No systemic issue or deficiency was identified.
Event or Problem Description
The abbott technician was performing preventative maintenance on the cell dyn ruby analyzer and was splashed in the eye when changing the hemoglobin reagent syringe.The technician was not wearing goggles.She flushed her eyes with water and went to the clinic to get medical care.The technician was given eye drops for treatment (moxifloxacina 0.5% hylo gel eyes drops).There was no reported impact to patient results or patient management.The technician was given eye drops for treatment (moxifloxacina 0.5% hylo gel eyes drops).

• 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: 22814280
• Report Number: 2919069-2025-00035
• Device Sequence Number: 12950867
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: (01)00380740017170
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 10/20/2025

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?: No
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown