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U.S. Department of Health and Human Services

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

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NANOSPHERE, INC. VERIGENE GRAM-NEGATIVE BLOOD CULTURE TEST (BC-GN) Back to Search Results
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.

 
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Brand NameVERIGENE GRAM-NEGATIVE BLOOD CULTURE TEST (BC-GN)
Type of DeviceGRAM-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 Key8809480
MDR Text Key151703269
Report Number3006028115-2019-00001
Device Sequence Number1
Product Code PEN
Combination Product (Y/N)N
PMA/PMN NumberK132843
Number of Events Reported1
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
Date FDA Received07/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/13/2019
Device MODEL Number20-006-021
Device Catalogue Number20-005-021
Device LOT Number031519021B
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/15/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/19/2019 Patient Sequence Number: 1
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