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

Model Number N/A

Device Problem Failure to Fold (1255)

Patient Problems Death (1802); Septic Shock (2068); Cardiogenic Shock (2262)

Event Date 11/09/2020

Event Type  Death  

Event 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 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
• Type of Device: VERIGENE I BC-GN ASSAY
• Manufacturer (Section D): LUMINEX CORPORTION; 4088 commercial avenue; northbrook IL 60062
• Manufacturer Contact: alina goodman ; 4088 commercial avenue; northbrook, IL 60062 ; 8474009077
• MDR Report Key: 11046263
• MDR Text Key: 222660155
• Report Number: 3006028115-2020-00002
• Device Sequence Number: 1
• Product Code: PEN
• UDI-Device Identifier: 00840487101599
• UDI-Public: 00840487101599
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2021
• Device Model Number: N/A
• Device Catalogue Number: 20-005-021
• Device Lot Number: 082620021A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 11/04/2020
• Supplement Dates FDA Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death