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

Model Number N/A

Device Problem False Positive Result (1227)

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

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

Verigene result 1: staphylococcus spp.And s.Aureus detected; verigene result 2: staphylococcus spp.Detected.Confirmatory testing biochemical testing and maldi to confirm s.Capitis.Patient was treated with vancomycin based on verigene result, but there was no serious injury, adverse effect, or death associated with the treatment.

Event Description

Customer reporting false positive for s.Aureus for verigene bc-gp assay.

• Brand Name: VERIGENE BLOOD CULTURE GRAM POSITIVE NUCLEIC ACID TEST KIT
• Type of Device: VERIGENE BC-GP
• Manufacturer (Section D): LUMINEX CORPORATION; 4088 commercial ave; northbrook IL 60062
• Manufacturer Contact: wendy ricker ; 1224 deming way; madison, WI 53717 ; 6082038936
• MDR Report Key: 10874890
• MDR Text Key: 219546205
• Report Number: 3006028115-2020-00001
• Device Sequence Number: 1
• Product Code: PAM
• UDI-Device Identifier: 00840487101575
• UDI-Public: 00840487101575
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122514
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/12/2020

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: 11/18/2020
• Device Model Number: N/A
• Device Catalogue Number: 20-006-018
• Device Lot Number: 052020018A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: 3006028115-10/9/2020-001
• Patient Sequence Number: 1