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	07/26/2024
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.This incident is being reported to fda because the incident occurred internationally using the alinity m system, list 08n53-002, which is also us fda approved.
Event or Problem Description
The customer reported a leak of diluent solution or liquid waste from the system solutions drawer from the alinity m instrument.The customer reported that the leak had spread beyond the footprint of the instrument.The customer reported error 5020: system solution (diluent) transfer error followed by error 2162: transferring for system solution disabled on attempting power cycle.Customer advised to clean up the spillage and discontinue use of the instrument.Customer reported no exposure to hazardous material as a result of the leak, and personal protective equipment (ppe) was worn as per normal laboratory procedures.No injuries were reported by the customer.
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: 19908675
• Report Number: 3005248192-2024-00128
• Device Sequence Number: 7174114
• Product Code: OOI
• UDI-Device Identifier: 00884999031753
• UDI-Public: (01)00884999031753(11)210331(240)08N53-002
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: 07/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown