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

Catalog Number	08H67-01
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
While working on a cell-dyn ruby analyzer, an individual made contact with a sample probe.The contact cut through the glove the individual was wearing and caused a small cut on the right index finger.The individual had their blood drawn and was provided the following regimen of anti-retroviral therapy (tenofovir 300mg, dolutegravir 50mg + lamivudine 300mg) to take daily initially for 3 days.There was no further user impact reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The instrument service history for the cell dyn ruby analyzer, serial # (b)(6) verifies no subsequent issues have been reported related to an injury from a part, after the current issue was identified.A review of tracking and trending of the open mode probe 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.A product labeling review of the cell-dyn ruby system operator¿s manual addresses safety hazards including warning, potential biohazard and physical hazards safe practices should be observed to avoid physical injury in the following situations: labeling cautions user vent needle tips are sharp; avoid contact with needle tips.Avoid contact with the tips of probes.The investigation determined the incident was due to a use error in that the field service representative(fsr) did not follow all required precautions as indicated in labelling, when servicing the instrument.The injury to the fsr¿s hand was not caused by any system malfunction and no systemic issue or deficiency of either the open mode probe or the cell dyn ruby analyzer were identified.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.No systemic issue or deficiency of either the open mode probe or the cell dyn ruby analyzer were identified.
Event or Problem Description
While working on a cell-dyn ruby analyzer, an individual made contact with a sample probe.The contact cut through the glove the individual was wearing and caused a small cut on the right index finger.The individual had their blood drawn and was provided the following regimen of anti-retroviral therapy (tenofovir 300mg, dolutegravir 50mg + lamivudine 300mg) to take daily initially for 3 days.There was no further user impact 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: 23864387
• Report Number: 2919069-2025-00052
• Device Sequence Number: 10006289
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: (01)00380740017170
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 02/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 12/13/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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: Male