MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ABBOTT M2000SP INSTRUMENT; CLINICAL SAMPLE CONCENTRATOR

Model 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	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint has been elevated for investigation.
Event or Problem Description
The customer reported there was a leak under the instrument of the waste tray of their alinity m system.Also confirmed no liquid reached any walking surface, that it was contained inside the instrument in the waste tray.The cause of the incident was that the waste line going to the liquid waste bottle was severed.The field service engineer (fse) replaced the waste line and decontaminated the waste drawer.Customer accepts instrument as no further action required.Customer reported observing dripping coming from waste tubing inside instrument cabinet.The customer stated that the leak may have been present after the instrument was moved recently as there were some dried up spots on the floor.The customer did not confirm whether the dry spots on the floor came from the instrument, however this form will be completed based on the worst-case scenario that the instrument was leaking onto the floor, onto a walking surface.The lab manager confirmed there was no exposure or injury related to the leak.
Additional Manufacturer Narrative
Investigation into this complaint included a service history review, a quality data review and a complaint history review.Investigation is summarized as follows: service history review: cmsnext service history review was performed to identify any additional tickets related to liquid waste.The review identified only the complaint ticket that is currently under investigation as being related.Quality data review: corrective and preventative action (capa) / non-conformance (nc) review did not identify any records that are related to this issue.Complaint history review: complaint history review showed that, over the last two years, the ticket currently under investigation and one other ticket where a liquid waste tubing was cracked causing liquid waste leakage, were the only two tickets associated with this observation.Based on the results of the investigation, no product deficiency was identified for the m2000sp e-series instrument, ln 09k14-02.
Event or Problem Description
The customer reported there was a leak under the instrument of the waste tray of their m2000sp instrument.
Additional Manufacturer Narrative
When reviewing complaint for closure it was identified that b5 stated the customer reported there was a leak under the instrument of the waste tray of their alinity m system.This mdr and the associated complaint ticket are in reference to observation of leakage on the m2000sp instrument, therefore b5 has been updated to reflect this.

• Brand Name: ABBOTT M2000SP INSTRUMENT
• Common Device Name: CLINICAL SAMPLE CONCENTRATOR
• 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: sarah parker ; 1300 e. touhy ave.; des plaines, IL 60018-3315 ; 2243617355
• MDR Report Key: 12463167
• Report Number: 3005248192-2021-00218
• Device Sequence Number: 3780104
• Product Code: JJH
• UDI-Device Identifier: 00884999031753
• UDI-Public: 00884999031753
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2022

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 Model Number: 09K14-02
• Device Catalogue Number: 09K14-02
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 09/22/2021; 03/22/2022
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 10/15/2021; 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2013
• 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