MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ALINITY M SYSTEM; REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM

Catalog Number	08N53-002
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is in process.A follow-up report will be submitted when the investigation is complete.
Event or Problem Description
The customer reported a leak on the right side of their alinity m instrument.The customer noticed a leak coming from under the right side of the instrument, a small amount of crystallization buildup under the lysis cradle, and some extra liquid waste in the solid waste bin.The customer checked the systems solutions drawer before calling and did not notice any damage to the liquid waste bottles or any tubing in the drawer.The customer stated that the liquid pool was about 12 inches in diameter and left the footprint of the instrument.The customer cleaned the spill with paper towels.The field service engineer (fse) performed troubleshooting and replaced the elution vapor barrier reservoir sensor and the lysis cradle.The fse inspected and cleaned the liquid waste extraction nozzles to remove any buildup and blockages.There was no injury to the customer from the leak.The customer cleaned the leak with personal protective equipment (ppe).
Additional Manufacturer Narrative
The complaint ticket has been reviewed and determined to be the same issue as described in a previously performed investigation.This investigation confirmed that the system solutions drawer enclosure design, which includes six thru holes at the bottom, allows liquid originating in the system solutions drawer to escape.Additionally, it confirmed the gems reservoir sensor may fail to detect a full reservoir bottle of liquid, resulting in a leak.Therefore, this complaint investigation will be dispositioned as confirmed and linked to the associated risk assessment.A complaint search of reportable events and leaks on the alinity m system was completed and a review of the frequency of exposure to hazards has determined that there is no change in the frequency of hazard or the frequency of harm related to exposure of a physical hazard (slip/fall), chemical hazard or biohazard (within the predefined risk management file level).

• Brand Name: ALINITY M SYSTEM
• Common Device Name: REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer Contact: albert chianello ; 1300 e. touhy ave.; des plaines, IL 60018-3315 ; 2242064064
• MDR Report Key: 19976029
• Report Number: 3005248192-2024-00131
• Device Sequence Number: 7057453
• Product Code: OOI
• UDI-Device Identifier: 00884999031753
• UDI-Public: (01)00884999031753(11)211109(240)08N53-002
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P190025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 08N53-002
• 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: 08/09/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown