MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT; VITEK® 2 NH ID TEST KIT

Catalog Number 21346

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in (b)(6) reported inconsistent results for a single organism strain in association with the vitek® 2 neisseria-haemophilus (nh) id test kit.On separate tests, the strain was identified as: (b)(6), unidentified organism, moraxella, neisseria meningitidis.There is no patient associated with the strain.The customer is performing "scientific work with modified strains"; hence the reason for multiple tests of the same type against the same strain.The (b)(6) identified the organism as (b)(6).Internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) reported inconsistent results for a single organism strain in association with the vitek 2 neisseria-haemophilus (nh) id test kit.An internal biomerieux investigation was performed.Results are as follows: the customer tested the isolates from chocolate agar with the correct mcfarland density.The bruker daltonik maldi biotyper identified the organisms as (b)(6)- no lab report was provided for the unidentified result.- for the lab report with a 99% moraxella catarrhalis result, there were two (2) atypical negative reactions (proa & dglu) according to the nh knowledge base for an identification of (b)(6).- for the report with a 94% n.Meningitidis result, there were five (5) atypical results (4 atypical negative: phea, proa, tyra, appa and 1 atypical positive: ure) according to the nh knowledge base for an identification of (b)(6).An increased number of (b)(6) 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.However.The increased number of (b)(6) reactions may have been caused by leaving the isolate out of co2 for an extended period of time.Since (b)(6) 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.There were no issues observed on initial qc performance testing.The investigation concluded there is no evidence to suggest the vitek 2 nh id card is performing outside of specifications.

• Brand Name: VITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 NH ID 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; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 5953632
• MDR Text Key: 55006012
• Report Number: 1950204-2016-00126
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• PMA/PMN Number: K842587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2017
• Device Catalogue Number: 21346
• Device Lot Number: 245376120
• Date Manufacturer Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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