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

Model Number	20-006-021
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: VERIGENE BC-GN,
• Manufacturer (Section D): LUMINEX CORPORATION; 4088 commercial ave; northbrook IL 60062
• Manufacturer Contact: alina goodman ; 4088 commercial ave; northbrook, IL 60062 ; 8474009077
• MDR Report Key: 12869294
• Report Number: 3006028115-2021-00003
• Device Sequence Number: 17627809
• Product Code: PEN
• UDI-Device Identifier: 00840487101599
• UDI-Public: 00840487101599
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown