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

Catalog Number 03R65-01

Device Problem Sparking (2595)

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

Event Date 12/11/2023

Event Type  malfunction  

Event Description

The customer stated that a reaction vessel had fallen into a gap inside the alinity i processing module instead of into the waste container.When the customer attempted to remove the reaction vessel using tweezers, momentary sparks were observed.There was no injury due to the incident.The customer stated that the waste container will not stay in place.A field service engineer (fse) was dispatched to inspect the alinity i processing module.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer stated that a reaction vessel had fallen into a gap inside the alinity i processing module instead of into the waste container.When the customer attempted to remove the reaction vessel using tweezers, momentary sparks were observed.There was no injury due to the incident.The customer stated that the waste container will not stay in place.A field service engineer (fse) was dispatched to inspect the alinity i processing module.

Manufacturer Narrative

The instrument service history review for ai22193 revealed no additional service tickets associated with electrical sparks.A review of tracking and trending for the alinity i processing module did not identify any trends.Review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.Return testing was not completed as returns were not available.No parts were identified or replaced as the cause of the issue, and the instrument remained functional.The 2023 ul certification memo indicates that abbott diagnostic equipment and accessories are certified to the appropriate safety standards, and adequate protection is provided for the operator against spread of fire from the equipment.The electrical spark observed was limited to the right of the rv waste on the module; the electrical spark did not spread to other parts of the module.Based on the investigation, no systemic issue or deficiency of the alinity i processing module, serial number (b)(6), was identified.

• 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: 18399472
• MDR Text Key: 331490539
• Report Number: 3016438761-2023-00687
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740137366
• UDI-Public: 00380740137366
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• 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: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1