MAUDE Adverse Event Report: NANOSPHERE INC. VERIGENE GRAM-POSITIVE BLOOD CULTURE NUCLEIC; BC-GP

Model Number 20-006-018

Device Problems False Positive Result (1227); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Toxicity (2333)

Event Date 02/12/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 sample (b)(6) was processed using the cartridge id (b)(4) verigene gram-positive blood culture nucleic acid test (bc-gp) on the verigene system.The result from the test was staphylococcus, s.Aureus, s.Epidermidis and mec a detected.The patient sample was also tested on maldi on (b)(6) 2015 and resulted as s.Hominis.The hosp facility notified nanosphere of the discrepancy between the bc-gp and maldi results on (b)(6) 2015.At that time nanosphere did not inquire if there was any adverse event to the patient; the hosp facility reported that the results had been released to a physician however they did not know if the therapy was altered and at the time no adverse event had been reported.Nanosphere again requested adverse event info on(b)(6) 2015.The hosp reported to nanosphere on (b)(6) 2015 only the bc-gp result of staphylococcus aureus was reported to the treating physician, and the patient was started on vancomycin therapy.The patient developed renal toxicity which may have been due to vancomycin, with multiple other factors involved in sickness, "hard to sort out".

Manufacturer Narrative

The bc-gp is an in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection.Bc-gp is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria.A trained health care professional should interpret the results together with the patients medical history, clinical signs and symptoms, and the result of other diagnostic tests.During the course of nanosphere's investigation into the discrepancy the hosp sent a blood culture aliquot of the patient sample labeled as " (b)(6)" which was received by nanosphere on 02/18/2015.Nanosphere processed the sample on the bc-gp test and received a staphylococcus detected result on 04/13/2015 and also processed it on the vitek 2 resulting in staphylococcus hominis spp hominis.The initial result on (b)(6) 2015 of s.Aureus, s.Epidermidis and mec a detected, appears inaccurate, the expected result of only staphylococcus detected is expected for a staphylococcus hominis organism on the bc-gp test.The negative agreement for s.Epidermidis, s.Aureus, and meca are within the expected positive agreement confidence interval for the respective target per the verigene bc-gp package insert and no other reports of false positive have been reported with lot 120914018a.The investigation at nanosphere concluded that the false positive results observed on test (b)(4), was isolated to that individual test.The specific test cartridge id (b)(4) was unavailable for further investigation.Without a complete understanding of the patient medical history or time lines regarding treatment and therapy from hosp facility nanosphere has chosen to submit the mdr with limited understanding of the adverse event or role of the bc-gp test in the therapy decision.

• Brand Name: VERIGENE GRAM-POSITIVE BLOOD CULTURE NUCLEIC
• Type of Device: BC-GP
• Manufacturer (Section D): NANOSPHERE INC.; 4088 commercial avenue; northbrook IL 60062
• Manufacturer Contact: 4088 commercial avenue; northbrook, IL 60062 ; 8474009000
• MDR Report Key: 4810601
• MDR Text Key: 5916139
• Report Number: 3006028115-2015-00001
• Device Sequence Number: 1
• Product Code: PAM
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2015

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: 06/07/2015
• Device Model Number: 20-006-018
• Device Catalogue Number: 20-005-018
• Device Lot Number: 120914018A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2015
• Initial Date FDA Received: 05/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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): Other