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

Model Number	09K14-02
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Elevated complaint investigation has been initiated.
Event or Problem Description
Customer reported the liquid waste connector on their m2000sp instrument was not working as expected, which caused dripping.Leakage occurred outside the instrument and reached the walking surface.The customer didn't get in contact with the liquid and personal protective equipment were used by the lab personnel.There was no injury associated with this observation.Local engineer confirmed the customer had no further issues.Discussed possible causes such as a not fully connected waste connector.Customer is then satisfied and therefore no further actions are required.No patient was involved as this observation was made by the m2000sp user.This incident is being reported to fda because the incident occurred in (b)(4) using the m2000sp instrument, list 9k14-02, which is also us fda approved.
Additional Manufacturer Narrative
Investigation into this complaint included an existing data review, a quality data review and a complaint history review.The investigation is summarized as follows: the ticket documented an event where a waste liquid connector was not working as expected on the m2000sp instrument (ln 09k14-02, sn (b)(6)) resulting in leaking on the floor.Review of current labeling concluded the manuals provide instructions for the operation and maintenance of the m2000sp instrument system and the replacement of the liquid waste tubing.Non-conformance and capa searches did not identify any related records associated with the reported issue.Complaint history review showed that over the last two years, elevated complaint ticket under investigation is the only ticket related to a leak due to a liquid waste connector issue resulting in a leak onto the walking surface.Based on the investigation elements, a product deficiency was not identified for the m2000sp instrument system ln 09k14-02.

• Brand Name: M2000SP INSTRUMENT
• Common Device Name: CLINICAL SAMPLE CONCENTRATOR
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines, il
• MDR Report Key: 10182039
• Report Number: 3005248192-2020-00023
• Device Sequence Number: 14068816
• Product Code: JJH
• UDI-Device Identifier: 00884999031753
• UDI-Public: 00884999031753
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K092705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

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: No Information
• Device Model Number: 09K14-02
• Device Catalogue Number: 09K14-02
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1