MAUDE Adverse Event Report: LUMINEX CORPORATION VERIGENE BLOOD CULTURE-GRAM NEGATIVE NUCLEIC ACID TEST KIT; VERIGENE BC-GN

Model Number 20-006-021

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2021

Event Type  malfunction  

Event Description

A customer had reported 'no call' internal control error on the verigene bc-gn assay.The 'no call' error had occurred during quality control (qc) testing.There was no patient involvement, no adverse event had occurred.There was a device malfunction, once additional information becomes available the information will be provided.

• Brand Name: VERIGENE BLOOD CULTURE-GRAM NEGATIVE NUCLEIC ACID TEST KIT
• Type of Device: VERIGENE BC-GN
• Manufacturer (Section D): LUMINEX CORPORATION; 4088 commercial ave; northbrook IL 60062
• Manufacturer Contact: alina goodman ; 4008 commercial ave; northbrook, IL 60062
• MDR Report Key: 12911560
• MDR Text Key: 286838970
• Report Number: 3006028115-2021-00009
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/01/2021

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 Expiration Date: 04/22/2022
• Device Model Number: 20-006-021
• Device Catalogue Number: 20-005-021
• Device Lot Number: 102221021A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2021
• 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