MAUDE Adverse Event Report: ILLUMINA SINGAPORE ILLUMINA NEXTSEQ¿ 550DX INSTRUMENT

Model Number	N/A
Medical Device Problem Codes	Leak/Splash (1354); Defective Component (2292)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Illumina internal reference # (b)(4).Salesforce case # (b)(4).On (b)(6) 2023, a customer reported that they observed a leak coming from their nextseq 550.The leak was discovered about 75% of the way through the run.The run proceeded for about 10 hours before the leak was discovered.It appears the waste disposal spout inside the sequencer was not hooked up to the waste tray appropriately.None of the waste went in the tray as it went inside the sequencer and spilled out.Most of the waste inside the sequencer waste caught in the reagent area, overflowed into the keyboard, and spilled on the floor.No harm or injury was reported.The customer was concerned about potential exposure to hazardous reagent waste.The customer cleaned up the spill per the customer's environmental, health, and safety (ehs) guidelines and was wearing the proper personal protective equipment (ppe).The initial investigation indicates user error may have potentially contributed to the waste container not being fully inserted.Furthermore, an illumina field service engineer (fse) found the waste sensor to be faulty.A faulty sensor could have falsely detected the waste tray to be fully inserted.The fse replaced the sensor and tested it.The fse also marked where the waste container should go for the customer to be able to see it is seated all the way.While no death or serious injury occurred, this is a repeat of the issue previously reported under mfr # 3007102730-2021-00001 and 3007102730-2022-00001 and is being reported due to having the potential to lead to harm which may cause medical intervention.This medwatch is being submitted as an initial and final medwatch.If new or additional information is received, illumina will submit a supplemental medwatch.
Event or Problem Description
The impacted product is the nextseq 550 sequencing system and serial number, which is a research use only (ruo) product.This product is similar to the nextseq¿ 550dx instrument in vitro diagnostic (ivd).The sequencing by synthesis (sbs) chemistry for the ruo instrumet is similar to the ivd instrument, therefore, this event is being reported as an mdr.Note: individual formulations may differ somewhat.The nextseq¿ 550dx instrument is intended for sequencing dna libraries with in vitro diagnostic assays.For its input, the nextseq¿ 550dx uses libraries generated from dna where sample indexes and capture sequences are added to amplified targets.Sample libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (sbs) chemistry.Sbs chemistry uses a reversible-terminator method to detect fluorescently labeled single nucleotide bases as they are incorporated into growing dna strands.On (b)(6) 2023, a customer reported that they observed a leak coming from their nextseq 550.The leak was discovered about 75% of the way through the run.The run proceeded for about 10 hours before the leak was discovered.It appears the waste disposal spout inside the sequencer was not hooked up to the waste tray appropriately.None of the waste went in the tray as it went inside the sequencer and spilled out.Most of the waste inside the sequencer waste caught in the reagent area, overflowed into the keyboard, and spilled on the floor.No harm or injury was reported.The customer was concerned about potential exposure to hazardous reagent waste.The customer cleaned up the spill per the customer's environmental, health, and safety (ehs) guidelines and was wearing the proper personal protective equipment (ppe).The initial investigation indicates user error may have potentially contributed to the waste container not being fully inserted.Furthermore, an illumina field service engineer (fse) found the waste sensor to be faulty.A faulty sensor could have falsely detected the waste tray to be fully inserted.The fse replaced the sensor and tested it.The fse also marked where the waste container should go for the customer to be able to see it is seated all the way.While no death or serious injury occurred, this is a repeat of the issue previously reported under mfr # 3007102730-2021-00001 and 3007102730-2022-00001 and is being reported due to having the potential to lead to harm which may cause medical intervention.

• Brand Name: ILLUMINA NEXTSEQ¿ 550DX INSTRUMENT
• Common Device Name: NEXTSEQ¿ 550DX INSTRUMENT
• Manufacturer (Section D): ILLUMINA SINGAPORE; 29 woodlands industrial park; e1, lobby 3, #02-13/18; north tech, 75771 6; SN 757716
• Manufacturer (Section G): ILLUMINA SINGAPORE; 29 woodlands industrial park; e1, lobby 3, #02-13/18; north tech, 75771 6; SN 757716
• Manufacturer Contact: steven azzoo ; 5200 illumina way; san diego, CA 92122
• MDR Report Key: 17075873
• Report Number: 3007102730-2023-00001
• Device Sequence Number: 17836709
• Product Code: PFF
• UDI-Device Identifier: 00816270020125
• UDI-Public: 00816270020125
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/06/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 20005715
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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