MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. M2000SP E-SERIES SYSTEM; CLINICAL SAMPLE CONCENTRATOR

Model Number	09K14-02
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An elevated complaint investigation will be conducted; a follow-up report will be sent once this is complete.
Event or Problem Description
During de-installation of m2000sp sn (b)(4) (094094re1851352), an abbott field service engineer (fse) had a liquid splash on his eyes from the waste tubing.The fse was wearing glasses.The fse cleaned his eyes after the splash.The instrument was noted to only have been used to run the hcv genotype assay.The fse has not been given any therapy outside of basic first aid; the fse provided a sample for blood analysis which shows negative results in all tested pathogens.The fse is noted to be doing well with no signs of injuries.
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 service history for m2000sp serial number (sn) (b)(6)revealed the instrument was installed 25-june-2019 at the complaint customer site in (b)(6).A review of service tickets did not identify any additional tickets related to the liquid waste system.Labeling review m2000sp operations manual 200681-109 - march 2016, was reviewed.Review concluded there is applicable labeling to identify the relevant information related to the m2000sp instrument in regard to cleaning the liquid waste bottle and the need to use appropriate ppe (personal protective equipment).Nonconformance (nc) / corrective and preventive action (capa) search a search of nc and capa (nc/capa) records was performed for instances related to the m2000sp instrument system, base list number (ln) 09k14.Capa history review did not identify any related records in the last two years.Complaint history review complaint history review was performed for the m2000sp instrument system, ln 09k14-02 and no product deficiency was identified.Based on the results of the investigation, a product deficiency was not identified for the m2000sp e series instrument system, ln 09k14-02.

• Brand Name: M2000SP E-SERIES SYSTEM
• 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: albert chianello ; 1300 e. touhy ave.; des plaines, IL 60018-3315 ; 2242064064
• MDR Report Key: 15749551
• Report Number: 3005248192-2022-00981
• Device Sequence Number: 19550319
• Product Code: JJH
• UDI-Device Identifier: 00884999031753
• UDI-Public: 00884999031753
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 12/08/2022

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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