MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY S SYSTEM; TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN

Catalog Number	06P16-01
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/24/2025
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
While cleaning a probe on the alinity s system, the probe went through glove of a field service engineer (fse) and cut their hand.The cut was immediately washed with soap, sterilized with alcohol, and a bandage was placed.It was reported that the instrument was offline when the event occurred.The individual went to an emergency department on (b)(6) 2025.Complete metabolic panel, hiv, hepatitis c, and hbsag laboratory tests were performed.No results were provided.The individual was started on emtricitabine tenofovir and raltegravir for hiv exposure prophylaxis.The individual was instructed to follow up with occupational health for any further care, such as rechecking laboratory testing.
Event or Problem Description
While cleaning a probe on the alinity s system, the probe went through glove of a field service engineer (fse) and cut their hand.The cut was immediately washed with soap, sterilized with alcohol, and a bandage was placed.It was reported that the instrument was offline when the event occurred.The individual went to an emergency department on (b)(6) 2025.Complete metabolic panel, hiv, hepatitis c, and hbsag laboratory tests were performed.No results were provided.The individual was started on emtricitabine tenofovir and raltegravir for hiv exposure prophylaxis.The individual was instructed to follow up with occupational health for any further care, such as rechecking laboratory testing.
Additional Manufacturer Narrative
A wash zone probe was being cleaned by a field service engineer (fse) on the alinity s system serial number (b)(6) when the probe cut the fse¿s hand.It was reported that the instrument was off when the event occurred and that there was no identified occurrence of an instrument malfunction that contributed to the injury.The instrument service history review revealed no additional complaints associated to the reported event.A review of tracking and trending did not identify an increase in complaint activity for the wash zone probe with regards to the reported event.Labeling was reviewed and was found to address the reported event, including mitigations to reduce contact with the probe.Based on the available information, the alinity s system serial number (b)(6) and wash zone probe met performance specifications and performed as intended.

• Brand Name: ALINITY S SYSTEM
• Common Device Name: TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 21599259
• Report Number: 1628664-2025-00002
• Device Sequence Number: 18400750
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: (01)00380740138479
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: BL125674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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: 06P16-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2020
• 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