MAUDE Adverse Event Report: LUMINEX CORPORATION VERIGENE BC-GP UTILITY REAGENT KIT

Catalog Number	20-012-018
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4).Upon further inspection, lower volumes of the labiase enzyme were observed in well 2 of the utility tray, as shown in figure 1 (attached).One of the trays had a visibly lower volume of reagent in well 2, compared to the product specification of 100±10 microliters.Nc-04966 and hra-23-0033 were initiated for the nonconforming material.There were no false results observed during final product testing for lot 062123018c.The labiase enzyme in the verigene bc-gp assay is an enzyme preparation useful for the lysis of enterococcus bacteria.Within nc-04966, it was determined that low volumes of the labiase enzyme could result in false-negative results, impacting e.Faecalis, e.Faecium, vana, and vanb.
Additional Manufacturer Narrative
It was determined that low volumes of the labiase enzyme could result in false-negative results, impacting e.Faecalis, e.Faecium, vana, and vanb.Per cra-13010, a single false negative efc/efl due to device malfunction or misuse would be reportable as a "serious injury." in general, enterococci are more likely to be resistant to beta-lactams and first-line antimicrobials than staph infections and more likely to be resistant to vancomycin than other bacterial species.Moreover, false negative efl/efc would preclude determination of vana or vanb mediated resistance.As such, the risk to health is greater because inadequate treatment is more likely if vre cannot be identified, and clinicians would likely not administer newer antibiotics such as such as linezolid, quinupristin/dalfopristin, daptomycin, telavancin, dalbavancin, and tigecycline.

• Brand Name: VERIGENE BC-GP UTILITY REAGENT KIT
• Common Device Name: VERIGENE BC-GP UTILITY REAGENT KIT
• Manufacturer (Section D): LUMINEX CORPORATION; 4088 commercial avenue; northbrook IL 60062
• Manufacturer Contact: lyndon white ; 12212 technology blvd; austin, TX 78727
• MDR Report Key: 17940622
• Report Number: 3006028115-2023-00002
• Device Sequence Number: 12339394
• Product Code: PAM
• UDI-Device Identifier: 00840487101629
• UDI-Public: 00840487101629
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122514
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 10/16/2023

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: 12/20/2023
• Device Catalogue Number: 20-012-018
• Device Lot Number: 062123018C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• 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