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

Model Number	09K14-02
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Elevated complaint investigation will be performed.
Event or Problem Description
Third party distributor received a shipment of m2000 reagent vessels.Upon receipt of the boxes, they realized that one of the cardboard boxes had broken, and inside the box one package of reagent vessels had broken, exposing a sharp edge.This box has been quarantined at the distributor warehouse and has not been sent to the end user customer.No injuries were sustained when the box was open or when the broken reagent vessel was handled.A total of 5 packets of reagent vessels were broken.There is no patient involved as the broken reagent vessels were identified by a third party distributor.According to the m2000sp operations manual (200681-109 - march 2016), up to six 200 ml reagent vessels hold the sample preparation reagents needed for automated sample preparation on the m2000sp instrument.
Additional Manufacturer Narrative
Report is being submitted as a correction as the summary of investigation was available on 8/3/2020 when the initial report was submitted but was not included.On 8/31/2020, this error was identified, and information was subsequently sent.Investigation into this complaint included an existing data review, a quality data review, a customer data review and a complaint history review.The investigation is summarized as follows: review of current labeling concluded that the operation manuals provide descriptions and instruction for the use and function of the 200ml reagent vessel.Non-conformance and corrective and preventive action (capa) searches identified no related records.Review of the photographs attached to the ticket was performed and supported the customer's description of issue.Complaint history review showed that over the last two years, elevated complaint ticket under investigation was the only ticket found related to the 200ml reagent vessel, ln 04j71-60, lot 11114400, found with a crack when the box was opened at the distributor site.Based on the investigation elements, a product deficiency was not identified for the 200ml reagent vessel, ln 04j71-60, lot 11114400.

• 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: 10359319
• Report Number: 3005248192-2020-00031
• Device Sequence Number: 2330306
• Product Code: JJH
• UDI-Device Identifier: 00884999031753
• UDI-Public: 00884999031753
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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: 07/08/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 08/03/2020
• 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