MAUDE Adverse Event Report: LUMINEX CORPORATION NORTHBROOK, IL VERIGENE I BC-GN ASSAY

Model Number N/A

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2020

Event Type  malfunction  

Event Description

A customer had reported a false positive oxa and kpc marker while utilizing verigene bc-gn assay.The customer had altered the therapy based on the verigne results, there was no adverse event or harm reported with this event.After further investigation of the event and product lot number, it was determined that the device had malfunctioned and provided false positive results due to non-specific binding.This was previously identified as a malfunction that was communicated to customers through a customer advisory notice (can) per recall 3006028115-10/9/2020-001-c (submitted to fda on 09 october 2020).At the time of the event, it was identified that the customer had not yet installed the latest software per the can instruction.The customer's software was updated on 19 november 2020 to mitigate any further issues.There was no patient injury or death identified as part of this event.In a case where updated information becomes available a follow-up report will be submitted.

• Brand Name: VERIGENE I BC-GN ASSAY
• Type of Device: VERIGENE I BC-GN ASSAY
• Manufacturer (Section D): LUMINEX CORPORATION NORTHBROOK, IL; 4088 commercial ave; northbrook IL 60062
• Manufacturer Contact: alina goodman ; 4088 commercial ave; northbrook, IL 60062 ; 8474009077
• MDR Report Key: 10931580
• MDR Text Key: 250318687
• Report Number: 3006028155-2020-00004
• 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
• Report Date: 12/01/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 20-005-021
• Device Lot Number: 070120021A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2020
• 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): Other