MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 NEISSERIA-HAEMOPHILUS (NH) IDENTIFICATION (ID) TEST KIT; VITEK® 2 NH ID CARD

Catalog Number 21346

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) contacted biomérieux to report a misidentification of neisseria gonorrhoeae as neisseria cinerea in association with the vitek® 2 neisseria-haemophilus (nh) identification (id) test kit.Repeat testing provided a low discrimination identification to n neisseria gonorrhoea / neisseria meningitidis.Due to suspicion of neisseria gonorrhoeae based on the appearance of the isolated colonies, the customer sent the isolate to a reference laboratory.The reference laboratory obtained identification neisseria gonorrhoeae via pcr testing and vitek® 2 nh id card.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.Culture submittal has been requested by biomérieux for internal investigation.However, the customer stated the strain is no longer viable for testing.Biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) contacted biomérieux to report a misidentification of neisseria gonorrhoeae as neisseria cinerea in association with the vitek® 2 neisseria-haemophilus (nh) identification (id) test kit.An internal investigation was completed.The strain was not submitted for evaluation.The strain was no longer viable.The customer reported testing the isolate from chocolate agar and incubating the plates in >3% co2 and that the initial test may have been with a suspension with a mcfarland density that did not meet nh culture requirements.Repeat testing was performed from a 48-hour culture, but no information was provided on the age of the culture for the initial testing.The reference lab performed testing on both the ms and nh card and obtained excellent identifications of n.Gonorrhoeae from both methods.Two lab reports were submitted.The first lab report showed an excellent identification of n.Cinerea with four atypical negative reactions (arga, tyra, appa, dglu) for an identification of n.Gonorrhoeae according to the nh knowledge base.The second lab report showed a low discrimination result of n.Gonorrhoeae and n.Meningitidis with two 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.Based on the information from the customer, it's possible that the mis-identifications may be due to set up errors such as: too low of an inoculum density on the initial testing, use of a 48-hour culture (18-24 hour is recommended) for the repeat testing, and co2 level being too low (5-10% is recommended).It should also be noted that the increased number of atypical negative reactions may be caused by leaving the isolate out of co2 for an extended period of time.Since n.Gonorrhoeae is a fastidious species, it needs to be contained in a co2 environment to retain robustness.If this species is left out on the bench outside of co2 for extended periods, it will become less robust and therefore less reactive in the nh card.Without the strain or raw data it's not possible to further evaluate the cause of the mis-identification.Vitek® 2 nh id card, lot# 2450336203 met final qc release criteria.This lot passed initial qc performance testing.

• Brand Name: VITEK® 2 NEISSERIA-HAEMOPHILUS (NH) IDENTIFICATION (ID) TEST KIT
• Type of Device: VITEK® 2 NH ID CARD
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6837680
• MDR Text Key: 86008590
• Report Number: 1950204-2017-00291
• Device Sequence Number: 1
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: CL. I 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: 11/06/2017

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: 10/28/2018
• Device Catalogue Number: 21346
• Device Lot Number: 2450336203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2017
• Initial Date FDA Received: 09/01/2017
• Supplement Dates Manufacturer Received: 10/10/2017
• Supplement Dates FDA Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2017
• 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