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	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Elevated complaint investigation will be performed.
Event or Problem Description
Customer reported the liquid waste tubing on her m2000sp instrument to be cracked and leaking.Customer stated that liquid had leaked to the floor as the instrument was running and the tubing has cracked.The customer decontaminated the system waste cabinet drawer as well as contained the spill on the floor by cleaning and decontaminating.No injuries and no exposure occurred in association with the leak.The customer successfully cleaned up the small puddle in front of the instrument.Field service engineer replaced the liquid waste tubing between the liquid waste bottle and waste station nozzles.No issue of leaks have been observed since service was performed.No patient was involved as this observation was made by the m2000sp user.
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: 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.Liquid waste assembly was identified as a spare part of the m2000sp e-series instrument.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, the complaint ticket currently being investigated, and one other independently investigated complaint ticket, were related to a leak due to a cracked liquid waste tubing resulting in a leak onto the floor.Based on the investigation elements, a product deficiency was not identified for the m2000sp instrument system ln 09k14-02, and the liq waste assembly, pn 04j72-10.

• 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: 10311058
• Report Number: 3005248192-2020-00029
• Device Sequence Number: 10965449
• Product Code: JJH
• UDI-Device Identifier: 00884999031753
• UDI-Public: 00884999031753
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 08/31/2020

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: 06/25/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1