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

Catalog Number	09K14-02
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An elevated complaint investigation will be performed.This incident is being reported to fda because the incident occurred in (b)(6) using the m2000sp instrument, list number 09k14-02 which is also approved for use in the united states.
Event or Problem Description
The abbott m2000 system is intended for use in performing nucleic acid testing in clinical laboratories.It is comprised of the abbott m2000sp and the abbott m2000rt instruments.The abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.The abbott m2000rt is an automated system for performing fluorescence-based pcr to provide quantitative and qualitative detection of nucleic acid sequences.The customer reported that the m2000sp instrument had leakage from the waste tube.The field service engineer (fse) was dispatched to the customer's location.The fse performed an inspection of the waste tubing.The waste tube had a crack where liquid waste poured out in the back of the m2000sp instrument cabinet, and the fse reported there was fluid on the floor.The customer wore gloves and a lab coat while cleaning up the fluid.The fse replaced the waste tube and completed a flush of the waste tube while looking and moving the waste tubing system.All checks and calibrations passed, the instrument was working per specification, and no further action was required.The customer accepted the instrument for routine use.This medical device report (mdr) is submitted on the basis that if this observation was caused by an abbot product malfunction and that malfunction were to recur, liquid leakage onto the walking surface has the potential to cause or contribute to serious injury or death.No patient was involved.The observation was made by the m2000sp instrument user.This incident is being reported to fda because the incident occurred in (b)(6) using the m2000sp instrument, list number 09k14-02 which is also approved for use in the united states.
Additional Manufacturer Narrative
Investigation into this complaint included a customer data review, quality data review, complaint history review and product/system/instrument evaluation.Investigation is summarized as follows: customer data review: the customer reported that liquid waste dripped from the liquid waste tubing onto the floor under the instrument cabinet.The customer cleaned the liquid waste from the floor while wearing personal protective equipment.Further clarification from the customer revealed some of the spill dripped onto the floor under the instrument cabinet but did not extend past the instrument cabinet and therefore did not present a slip hazard.The resolution was to replace the liquid waste tubing.Quality data review: no related non-conformances or capa records were found related to cracked/leaking liquid waste tubing.Complaint history review showed that, over the last two years, no other related complaints were identified.Product/system/instrument evaluation service history review was performed for m2000sp e-series instrument serial number (b)(4).The review of all tickets did not indicate a systemic m2000sp instrument performance issue or previous reports of leaking tubing.Liquid waste tubing part number 30098435 was worn out from normal use with a crack which leaked liquid waste onto the floor under the cabinet.The m2000sp operations manual contains adequate information about the biohazard nature of liquid waste and spill clean-up.Service manual review found the replacement spare part number and adequate instructions for replacement of the liquid waste tubing part number 30098435.Based on the results of investigation, no product deficiency has been identified.

• 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
• MDR Report Key: 7965057
• Report Number: 3005248192-2018-00013
• Device Sequence Number: 13811305
• Product Code: JJH
• UDI-Device Identifier: 00884999031753
• UDI-Public: 00884999031753
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 11/08/2018

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 Catalogue Number: 09K14-02
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1