MAUDE Adverse Event Report: LUMINEX CORPORTION VERIGENE I BC-GN ASSAY

Model Number	N/A
Medical Device Problem Code	Failure to Fold (1255)
Health Effect - Clinical Codes	Death (1802); Septic Shock (2068); Cardiogenic Shock (2262)
Date of Event	11/09/2020
Type of Reportable Event	Death
Event or Problem Description
A customer had reported a false negative ctx-m marker while utilizing verigene bc-gn assay.The patient was admitted on (b)(6) 2020 due to anasarca, the patient had expired on (b)(6) 2020 at 2:14 pm.The cause of death reported by the customer is septic and cardiogenic shock.Patient was on levofloxacin and doxycycline since admission.Meropenem and linezolid started (b)(6) 2020 around 1 am at the patient time of death, the medications (meropenem and linezolid) were removed from the patients treatment and no longer administered.Verigene bc-gn assay run on (b)(6) 2020, patient expired the same day; 4 hours after verigene result completed of septic like symptoms.The customer reported that the treatment was not amended due to the verigene reporting.The investigation is ongoing and if additional information becomes available, a follow-up report will be submitted.
Event or Problem Description
A customer had reported a false negative ctx-m marker while utilizing verigene bc-gn assay on (b)(6) 2020.On (b)(6) 2020, after further investigation it was determined that the device was performing per performance specification per the package insert, and there was no indication of a device malfunction.

• Brand Name: VERIGENE I BC-GN ASSAY
• Common Device Name: VERIGENE I BC-GN ASSAY
• Manufacturer (Section D): LUMINEX CORPORTION; 4088 commercial avenue; northbrook IL 60062
• MDR Report Key: 11046263
• Report Number: 3006028115-2020-00002
• Device Sequence Number: 16405781
• Product Code: PEN
• UDI-Device Identifier: 00840487101599
• UDI-Public: 00840487101599
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K132843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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: Health Professional
• Device Expiration Date: 02/26/2021
• Device Model Number: N/A
• Device Catalogue Number: 20-005-021
• Device Lot Number: 082620021A
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 12/21/2020
• 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: Death