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

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	05/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Illumina internal reference # (b)(4).Salesforce case # (b)(4).On (b)(6) 2022, a customer reported that after the run was completed on their nextseq 500, the waste had leaked as the waste bottle was not placed correctly during the run.No harm or injury was reported, but the customer reported being concerned about slipping on the waste liquid as well as exposure to the harmful components of the nextseq run spilled over the floor.While no death or serious injury occurred, this is a repeat of the issue previously reported under mfr # 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 500 sequencing system and serial number (b)(4), 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 instrument 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) 2022, a customer reported that after the run was completed on their nextseq 500, the waste had leaked as the waste bottle was not placed correctly during the run.No harm or injury was reported, but the customer reported being concerned about slipping on the waste liquid as well as exposure to the harmful components of the nextseq run spilled over the floor.While no death or serious injury occurred, this is a repeat of the issue previously reported under mfr # 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: 14691958
• Report Number: 3007102730-2022-00001
• Device Sequence Number: 6692547
• Product Code: PFF
• UDI-Device Identifier: 00816270020125
• UDI-Public: 00816270020125
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2022

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
• 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: 05/19/2022
• Initial Report FDA Received Date: 06/15/2022
• 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