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

Catalog Number	08H67-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/30/2025
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 field service representative (fsr) was onsite troubleshooting instrument error messages on the cell dyn ruby analyzer and identified the mixer head had a leak.During replacement of a spare part, the fsr was punctured with the sample probe.He immediately washed the area with soap, applied pressure to the laceration, and cleaned it with an antiseptic wipe.The fsr was treated in the emergency department and was prescribed a one month course of anti-retroviral therapy.No additional impact/treatment to the field service representative was reported.
Additional Manufacturer Narrative
The field service representative (fsr) was troubleshooting the cell dyn ruby analyzer and while reaching for the mixer inadvertently punctured himself with the open mode probe.An instrument service history review for serial number (b)(6) verified no subsequent issues have been reported related to an injury from a part, after the current issue was identified.A review of complaint and trending data associated with the open mode probe did not identify an increase in complaint activity.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 information provided by service, the injury to the fse is attributed to use error as the fse¿s inattention when troubleshooting the mixer issue, attributed to his injury.Based on the investigation the cell dyn ruby analyzer for serial number (b)(6) is performing as intended, no systemic issue or deficiency of the cell dyn ruby analyzer or the open mode probe was identified.
Event or Problem Description
The field service representative (fsr) was onsite troubleshooting instrument error messages on the cell dyn ruby analyzer and identified the mixer head had a leak.During replacement of a spare part, the fsr was punctured with the sample probe.He immediately washed the area with soap, applied pressure to the laceration, and cleaned it with an antiseptic wipe.The fsr was treated in the emergency department and was prescribed a one month course of anti-retroviral therapy.No additional impact/treatment to the field service representative was 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: 22358625
• Report Number: 2919069-2025-00028
• Device Sequence Number: 15617133
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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: 06/16/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2017
• 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