MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 NH TEST KIT

Catalog Number 21346

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a misidentification of a neisseria gonorrhoeae external quality control sample (eeq) as neisseria meningitides in association with the vitek® 2 nh test kit.The customer tested the sample twice with the nh card and the result was neisseria meningitides (97%).The expected result was neisseria gonorrhoeae.The customer tested a campylobacter as the internal quality control which passed.There was no patient involvement.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer reported to biomérieux a misidentification of a neisseria gonorrhoeae external quality control sample (eeq) as neisseria meningitides in association with the vitek® 2 nh test kit.An investigation was performed.The customer reported setting up a 24 hour culture from pvx that had been incubated in co2.Two lab reports were submitted and both showed an excellent identification of n.Meningitidis.One lab report showed three (3) atypical negative reactions (arga, tyra, appa) and the second lab report showed two (2) atypical negative reactions (tyra, appa) for an identification of n.Gonorrhoeae according to the nh knowledge base.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.However without the strain, lab reports or raw data it's not possible to further evaluate the cause of the misidentification.For fastidious species such as n.Gonorrhoaeae, it is important to limit the amount of time the culture is out of co2.This species will begin to show decreased viability and therefore less reactivity in the nh card when out of co2 for an extended period of time.The vitek 2 nh lot # 2450361203 met final qc release criteria.This lot passed qc performance testing.

• Brand Name: VITEK® 2 NH TEST KIT
• Type of Device: VITEK® 2 NH TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 7142263
• MDR Text Key: 95797224
• Report Number: 1950204-2017-00479
• Device Sequence Number: 1
• Product Code: JST
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

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 Operator: Health Professional
• Device Expiration Date: 11/22/2018
• Device Catalogue Number: 21346
• Device Lot Number: 2450361203
• Other Device ID Number: 03573026144357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 03/01/2018
• Supplement Dates FDA Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1