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

Model Number	N/A
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: VERIGENE I BC-GN ASSAY
• Manufacturer (Section D): LUMINEX CORPORATION NORTHBROOK, IL; 4088 commercial ave; northbrook IL 60062
• MDR Report Key: 10931580
• Report Number: 3006028155-2020-00004
• Device Sequence Number: 3369679
• Product Code: PEN
• UDI-Device Identifier: 00840487101599
• UDI-Public: 00840487101599
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 12/02/2020
• 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: Other