MAUDE Adverse Event Report: LUMINEX CORPORATION VERIGENE I EP TEST KIT

Catalog Number 20-005-023

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Stroke/CVA (1770)

Event Date 04/19/2022

Event Type  malfunction  

Event Description

Mbm reported potentially discrepant ep results on a pediatric patient sample at blanchard valley health system.Two different samples from the same patient were collected and ran 3 times on the ep assay, obtaining negative results.The patient was then sent to cincinnati children's hospital and tested positive for toxigenic e.Coli.On (b)(6) 2022, the customer reported that the patient has been put on dialysis and had a stroke on (b)(6) 2022.Verigene run 1 (date, (b)(6) 2022 sample, (b)(6): all targets not detected verigene run 2 (date, (b)(6) 2022 sample, (b)(6): all targets not detected verigene run 3 (date, (b)(6) 2022 sample, (b)(6): all targets not detected.Bd max ep: toxigenic e coli (tested at cincinnati children's) *luminex has requested multiple times the date the bd max was run and what sample was utilized for this run.As of 6/3/2022 the customer site has not provided this information.

Manufacturer Narrative

Per (b)(4), ep is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological information, and also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.Ep results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.For shiga toxins 1 and 2, yersinia, vibrio, norovirus, and rotavirus, the physician will consider the patient's symptoms to determine continuation of empiric antibiotic as these pathogens are generally self limiting and do not require treatment.The most common occurrence for these pathogens is that the disease will have lessened in severity, and the physician may choose to discontinue antibiotics (anti-virals are not effective for norovirus and rotavirus).The impact to patient care of the false negative result will be minimized to a delay in the de-escalation of empiric therapy until improved symptoms support the decision.In review of all associated customer-provided documentation and internal investigation notes against the criteria set forth in document 00043 (medical device reporting standard operating procedure), mdr-22-034 was initiated.Evidence evaluated during the course of this investigation do not indicate that any device removals and/or corrections associated with this complaint record were executed to reduce a risk to health posed by a device or to remedy a violation of the act caused by a device which may present a risk to health.However, the potentially discrepant result is associated with an alteration in patient care and will be submitted to the us fda.

• Brand Name: VERIGENE I EP TEST KIT
• Type of Device: VERIGENE I EP TEST KIT
• Manufacturer (Section D): LUMINEX CORPORATION; 12212 technology blvd; austin TX 78727
• Manufacturer Contact: jennifer svoboda ; 12212 technology blvd; austin, TX 78727
• MDR Report Key: 14705346
• MDR Text Key: 302580603
• Report Number: 1650733-2022-00034
• Device Sequence Number: 1
• Product Code: PCH
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 20-005-023
• Device Lot Number: 033022023A,031822023B,032322C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2022
• Initial Date FDA Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• 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
• Patient Outcome(s): Hospitalization; Other