MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY I PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number 03R65-01

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

The customer was performing buffer unload procedure 1209, the concentrated wash buffer reservoir out tubing was disconnected with force and splashed the customer in the left eye.The customer was not wearing safety glasses or using an eye shield.An instrument service history was reviewed and revealed no contributing factors on or around the date of the complaint.There have been no subsequent contacts from the customer regarding splashing occurrence since the reported incident.A review of tracking and trending of the immunoassay systems did not identify any trends related to the alinity i system, the wash buffer reservoir out tubing, or issues for splashing as described in this complaint.The device history records were reviewed, and no non-conformances or deviations were identified.Labeling was reviewed and found to be adequate.Based on the review of the issue, a use error may have contributed to the exposure described in this complaint as the customer was not wearing protective eyewear while handling human-sourced materials.Based on the investigation, no systemic issue or deficiency of the alinity i processing module serial number (b)(6) or the wash buffer reservoir out tubing was identified.

Event Description

The customer was splashed in her left eye with the wash buffer solution while performing procedure 1209 (empty bulk solution reservoirs) in the back of the alinity i processing module.The splashed occurred while the wash buffer tubing was being disconnected.The customer was not wearing safety glasses at the time of the incident.She rinsed her eyes with water and did not seek any medical treatment.The customer stated that she is doing fine.There was no further impact to the user.There was no patient involvement.

• Brand Name: ALINITY I PROCESSING MODULE
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18682628
• MDR Text Key: 335417762
• Report Number: 3016438761-2024-00081
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03R65-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female