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

Catalog Number	21346
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from (b)(6) reported a misidentification of (b)(6) quality control samples as moraxella catarrhalis, when using the vitek® 2 nh test kit (lot 2450570403).The customer tested four isolates provided by a reference lab ((b)(6)) in which identification was established as (b)(6).The results on the four strains were: (b)(6).The customer confirmed the identification of (b)(6) with the maldi method.The customer tested the lot with the (b)(6), which gave an acceptable result.There was no patient involvement as the event pertained to a qc sample.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was performed due to a customer report of misidentification of neisseria gonorrhoeae quality control samples as moraxella catarrhalis, when using the vitek® 2 nh test kit.Four isolates of neisseria gonorrhoeae were provided to the customer by a reference lab for internal qc testing.The identifications of the strains were confirmed by maldi.The strains were set up on chocolate agar, a minimum of 18 hours of growth, and incubated in co2.The customer reported that the strains were no longer viable for submittal for the investigation.Four lab reports were received.One lab report submitted had an excellent identification of moraxella catarrhalis with two atypical negative reactions (glu, proa) for an identification of neisseria gonorrhoeae according to the nh knowledge base.Two lab reports submitted had low discrimination calls of n.Cinerea/elongate/gonorrhoeae.One low discrimination lab report had one atypical negative reaction (glu) and the other low discrimination lab report had two atypical negative reactions (glu, appa) for an identification of neisseria gonorrhoeae according to the nh knowledge base.The fourth lab report had an "unidentified organism" call with one atypical negative reaction (glu) for an identification of neisseria gonorrhoeae according to the nh knowledge base.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.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.Without the strain or raw data it's not possible to further evaluate the cause of the misidentification.The vitek 2 nh lot #2450570403 met final qc release criteria.The lot passed qc performance testing.

• Brand Name: VITEK® 2 NH TEST KIT
• Common Device Name: VITEK® 2 NH TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood 63042
• MDR Report Key: 7798293
• Report Number: 1950204-2018-00290
• Device Sequence Number: 16190986
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2019
• Device Catalogue Number: 21346
• Device Lot Number: 2450570403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1