MAUDE Adverse Event Report: ILLUMINA HAYWARD ILLUMINA MISEQDX INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Illumina internal reference # (b)(4), salesforce case # (b)(4).It was a minor burn and the fse did not require medical attention.No harm, death, or serious injury was reported.This 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 miseq system, which is a research use only (ruo) product.This product is like or similar to the miseqdx 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 miseqdx instrument is intended for targeted sequencing of dna libraries from human genomic dna extracted from peripheral whole blood or formalin-fixed, paraffin-embedded (ffpe) tissue, when used with in vitro diagnostic (ivd) assays performed on the instrument.The miseqdx instrument is not intended for whole genome or de novo sequencing.The miseqdx instrument is to be used with registered and listed, cleared, or approved ivd reagents and analytical software.On august 20, 2025, an illumina field safety engineer (fse) was at the customer site to perform optical adjustment while installing a new solid state drive (ssd).During installation, the fse observed smoke and brown discoloration on the cable as well as a burnt hole in the black out cloth.The source was traced to a flow sensor cable.The cable was then unplugged and the instrument was shut down immediately per field instructions.The fse confirmed that they burned their hand when disconnecting the cable.It was a minor burn and the fse did not require medical attention.No harm, death, or serious injury was reported.Please note: in a standard lab setting, the flow sensor cable is contained within a fire box within the instrument.Therefore, a lab operator would not be exposed to this type of malfunction.

• Brand Name: ILLUMINA MISEQDX INSTRUMENT
• Common Device Name: ILLUMINA MISEQDX INSTRUMENT
• Manufacturer (Section D): ILLUMINA HAYWARD; 25841 industrial blvd; hayward CA 94545
• Manufacturer (Section G): ILLUMINA HAYWARD; 25841 industrial blvd; hayward CA 94545
• Manufacturer Contact: steven azzoo ; 5200 illumina way; san diego, CA 92122
• MDR Report Key: 23023144
• Report Number: 3005095756-2025-00001
• Device Sequence Number: 13182174
• Product Code: PFF
• UDI-Device Identifier: 00816270020002
• UDI-Public: 00816270020002
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 15036706
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown