MAUDE Adverse Event Report: NANOSPHERE, INC. VERIGENE GRAM-NEGATIVE BLOOD CULTURE TEST (BC-GN)

Model Number 20-006-021

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802); Unspecified Infection (1930)

Event Date 06/10/2019

Event Type  Death  

Manufacturer Narrative

There is no indication or allegation from the field/clinic that the device contributed to the incident.Luminex's investigation has determined that this is not a device malfunction.The product is adequately labeled and the product performed according to product claims.Luminex has made multiple requests for additional information from the medical director with regards to this case, but has not received any more information.Luminex's investigation was not able to determine root cause as the patient sample was discarded and not available for internal testing.Instrument and consumable data was reviewed and documentation showed no indication of device or consumable malfunction.The package insert labeling clearly states in rare instances for specimens with organisms carrying a resistance marker, bc-gn may not yield a positive result for the resistance marker when the organism(s) is detected.The package insert labeling states: bc-gn is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections.The package insert labeling states: a not detected result for any of the antimicrobial resistance markers does not indicate susceptibility, as resistance may occur by other mechanisms.Sub-culturing and ast testing is required in order to assign a resistant and/or susceptible phenotype to each isolate recovered from the blood culture sample.

Event Description

On (b)(6) 2019 sample (b)(6) was processed using the cartridge id (b)(6) verigene gram-negative blood culture test (bc-gn) on the verigene system.Verigene result was pseudomonas aeruginosa detected and reported out to a physician on (b)(6) 2019.Patient sample was run on vitek, and the vitek result was reported on (b)(6) 2019 as p.Aeruginosa identified, cefazolin and meropenem resistant.The hospital facility notified luminex (nanosphere) of the discrepancy between the bc-gn and vitek results on (b)(6) 2019 and provided details of the treatment.The patient was treated with meropenem and tobramycin for 48 hours following the verigene result.Following the vitek result, treatment was altered and meropenem was discontinued on (b)(6) 2019.Ciprofloxacin and avycaz were added to treatment on (b)(6 2019.On (b)(6) 2019, the patient expired from cardiac arrest.

• Brand Name: VERIGENE GRAM-NEGATIVE BLOOD CULTURE TEST (BC-GN)
• Type of Device: GRAM-NEGATIVE BLOOD CULTURE TEST
• Manufacturer (Section D): NANOSPHERE, INC.; 4088 commercial avenue; northbrook IL 60062
• Manufacturer (Section G): NANOSPHERE, INC.; 4088 commercial avenue; northbrook IL 60062
• Manufacturer Contact: greg maschek ; 12212 technology blvd; austin, TX 78727 ; 5122195195
• MDR Report Key: 8809480
• MDR Text Key: 151703269
• Report Number: 3006028115-2019-00001
• Device Sequence Number: 1
• Product Code: PEN
• UDI-Device Identifier: 00857573006140
• UDI-Public: 00857573006140
• Combination Product (y/n): N
• PMA/PMN Number: K132843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 07/19/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2019
• Device Model Number: 20-006-021
• Device Catalogue Number: 20-005-021
• Device Lot Number: 031519021B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2019
• 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): Death
• Patient Age: 62 YR