MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. M2000SP INSTRUMENT E-SERIES; REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM

Catalog Number	09K14-02
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
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 from their liquid waste container on their m2000sp system.The customer reported a leak from their liquid waste container.The leak was under the instrument and on the floor in front of the instrument.The leak was occurring from the connector on the container lid of the liquid waste container.The customer reported that they could see that the rubber on the connector was breaking.The customer reported that they wore appropriate personal protective equipment (ppe) to clean up the leak.A technical application specialist (tas) ordered a new liquid waste assembly for the customer.The customer was able to install the correct parts and continue to utilize the instrument.The instrument was performing per specification and the customer accepted the instrument for routine use.There was no report of injury or actual exposure to the leak.There was no patient involvement as the leak was identified by the m2000sp system user.
Additional Manufacturer Narrative
Investigation into this complaint included a supporting information review, quality data review, and a complaint history review.The results of the investigation are summarized as follows: supporting information review: the m2000sp operations manual 200681-109-march 2016, was reviewed.Review concluded the manual contains: biosafety procedures and biological and safety warnings are provided throughout the manual.Warnings regarding the risk of potentially infectious materials and caution to utilize appropriate biohazard precautions were found in the daily maintenance section.Section 8 contains general information about biological hazards, chemical hazards, and spill clean up.Use of appropriate ppe (personal protective equipment) was stressed.Section 8 additional has cleansing procedures for biohazardous exposure.Quality data review: a search of nonconformance and capa records was performed related to the m2000sp instrument base list number 09k14.The query for base 09k14 revealed no records associated with base 9k14 and the reported issue.Complaint history review: a complaint search was performed to identify any similar complaints to the ticket being investigated.Complaint trending was performed and did not identify a trend violation.A product deficiency was not identified by this evaluation.Based on the results of the investigation, a product deficiency was not identified for the m2000sp instrument, list 09k14-02.

• Brand Name: M2000SP INSTRUMENT E-SERIES
• 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
• MDR Report Key: 19575546
• Report Number: 3005248192-2024-00111
• Device Sequence Number: 15556119
• Product Code: OOI
• UDI-Device Identifier: 00884999031753
• UDI-Public: (01)00884999031753(240)09K14-02
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K092705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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
• Device Catalogue Number: 09K14-02
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2011
• 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
• Patient Sex: Unknown