MAUDE Adverse Event Report: LUMINEX CORPORATION VERIGENE® ENTERIC PATHOGENS NUCLEIC ACID TEST; VERIGENE® EP ASSAY STOOL PREP BUFFER KIT

Model Number 30-002-023

Device Problem Chemical Problem (2893)

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

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

The defective floq swab lot was identified via customer complaint (b)(4).Within the complaint, the issue was identified prior clinical use and no patient results were impacted.Although there's no health risk associated with the complaint case event, the product deficiency's potential to impact assay performance warrants an mdr.Per the medical device reporting for manufacturers guidance aligning with 21 cfr 803.3 and 803.50, the malfunction results in the failure of the device to perform its essential function and compromises the device's therapeutic, monitoring, or diagnostic effectiveness, which could cause or contribute to a death or serious injury, or other significant adverse device experiences required by regulation.

Event Description

On (b)(6) 2023, (b)(6) hospital notified luminex that they observed their ep stool prep kit not absorbing the cary blair buffer properly.The customer was unaware of which specific kit the swabs originated from.Lot of swab provided: 247p17 - ln:202699 exp 4/30/2025; ep kit lot not known as stool prep kits were separated from shipment.No patient samples were affected by the swab condition.

• Brand Name: VERIGENE® ENTERIC PATHOGENS NUCLEIC ACID TEST
• Type of Device: VERIGENE® EP ASSAY STOOL PREP BUFFER KIT
• Manufacturer (Section D): LUMINEX CORPORATION; 4088 commercial avenue; northbrook IL 60062
• Manufacturer Contact: jordan smith ; 1224 deming way; madison, WI 53717
• MDR Report Key: 16854218
• MDR Text Key: 314401147
• Report Number: 3006028115-2023-00001
• Device Sequence Number: 1
• Product Code: PCH
• UDI-Device Identifier: 00840487101568
• UDI-Public: 00840487101568
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140083
• 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: 05/02/2023

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 Model Number: 30-002-023
• Device Catalogue Number: 30-002-023
• Device Lot Number: 202699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2023
• Initial Date FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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