MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY HQ ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number	09P68-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Blurred Vision (2137); Burning Sensation (2146)
Date of Event	12/12/2025
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
An abbott field service representative (fsr) was sprayed in both eyes while flushing the waste line during preventative maintenance on the alinity hq processing module.While flushing the waste lines with bleach, a tubing connection popped off, causing fluid to spray into both eyes.The fsr flushed his eyes with water and reliwash saline eye wash (sodium chloride 0.9% w/v ph.Eur) for 10¿15 minutes.He then sought medical attention, where he received additional saline irrigation and was prescribed an antibiotic eye ointment (chloramphenicol 1.0%).Symptoms included burning and blurred vision, all of which have since resolved.The ointment was discontinued on (b)(6) 2025, and the fsr has fully recovered.At the time of the incident, the fsr was wearing a lab coat and gloves but was not wearing goggles.No further impact to patient management was reported.
Additional Manufacturer Narrative
Section b5 - describe event or problem: this section was updated with additional information provided on 06jan2026.An abbott field service representative (fsr) was sprayed in both eyes with bleach during the performance of the alinity hq high-volume pm 1 procedure, aspiration/dispense subsystem waste chamber tubing inspection.While using a syringe to flush bleach through the tubing, the connection disengaged and sprayed bleach into the fsr¿s eyes.At the time of the incident, the fsr was wearing a lab coat and gloves but was not wearing goggles.A review of the instrument¿s service history for serial number (b)(6) revealed no additional tickets associated with personal injury.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to the issue.A review of tracking and trending data for the alinity hq processing module did not identify any similar issues as described in this complaint.A review of the manufacturing documentation did not identify any nonconformances associated with the complaint issue.Labeling was reviewed and found to be adequate.In this case, a use error was identified, as the fsr was not wearing required ppe (safety goggles/face shield).The alinity h-series operations manual addresses biohazard and chemical hazard awareness and operator responsibility.The alinity hq high-volume pm 1 procedure provides instruction for performing the waste chamber tubing inspection and cleaning.Based on the investigation, the alinity hq processing module, serial number (b)(6), is performing as intended.No systemic issue or deficiency of the alinity hq processing module was identified.
Event or Problem Description
An abbott field service representative (fsr) was sprayed in both eyes while flushing the waste line during preventative maintenance on the alinity hq processing module.While flushing the waste lines with bleach, a tubing connection popped off, causing fluid to spray into both eyes.The fsr flushed his eyes with water and reliwash saline eye wash (sodium chloride 0.9% w/v ph.Eur) for 10¿15 minutes.He then sought medical attention, where he received additional saline irrigation and was prescribed an antibiotic eye ointment (chloramphenicol 1.0%).Symptoms included burning and blurred vision, all of which have since resolved.The ointment was discontinued on (b)(6) 2025, and the fsr has fully recovered.At the time of the incident, the fsr was wearing a lab coat and gloves but was not wearing goggles.No further impact to patient management was reported.Update: on 06jan2026, the fsr clarified that the tubing that popped off was attached to the syringe and not a part used for the preventative maintenance.

• Brand Name: ALINITY HQ ANALYZER
• 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: 23836399
• Report Number: 2919069-2025-00051
• Device Sequence Number: 5093641
• Product Code: GKZ
• UDI-Device Identifier: 00380740138851
• UDI-Public: (01)00380740138851
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K220031
• 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): 01/26/2026

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: 09P68-01
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• 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