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

Catalog Number 21346

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from the united states notified biomérieux of misidentification results for a cap survey strain when testing with vitek® 2 nh id test kit.The expected identification is acinetobacter lwoffi, acinetobacter junii (lwoffi/johnsonii), or acinetobacter sp.When testing this strain with the nh id card, the strain was identified as moraxella (branhamella) catarrhalis.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from the united states notified biomérieux of misidentification results for a cap survey strain when testing with vitek® 2 nh id test kit.The expected identification is acinetobacter lwoffi, acinetobacter junii (lwoffi/johnsonii), or acinetobacter sp.When testing this strain with the nh id card, the strain was identified as moraxella (branhamella) cattarhalis.An investigation was performed.The customer's cap d-09 strain and the internal biomerieux cap d-09 survey strain were subbed on tsab and tested in duplicate on one of the customer card lots of gn cards (the second gn lot implicated by the customer had expired), a random gn card lot, and the nh card lot implicated by the customer.Api 20 ne was also performed.911690 (customer's d-09 strain): on all 4 gn cards tested, an identification of slashline: moraxella group was obtained.On the nh card, a low discrimination call of campylobacter coli/campylobacter fetus ssp fetus was obtained.When api 20 ne was performed, a good identification (91.7%) of a.Lwoffii was obtained.911691 (internal d-09 strain): on all 4 gn cards tested, a low discrimination call of acinetobacter lwoffii / moraxella group was obtained.On the nh card, a low discrimination call of campylobacter coli/campylobacter fetus ssp fetus was obtained.When api 20 ne was performed, a good identification (91.7%) of a.Lwoffii was obtained.Since a.Lwoffii was part of the low discrimination call on gn cards, cards are performing as expected for this isolate.A comparison of reaction results for cards giving the misidentification of slashline: moraxella group against expected reactions for a.Lwoffii showed 1 atypical negative reaction (tyra) which led to the incorrect call.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.The nh card is not the appropriate card for testing this strain (a.Lwoffii) - -the nh card knowledge base does not include a.Lwoffii as a claimed species.The following statement is included in the product labeling for cards: "testing of an unclaimed species may result in an unidentified result or a misidentification.".

• Brand Name: VITEK® 2 NH TEST KIT
• Type of Device: VITEK® 2 NH TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: candace martin ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 7875081
• MDR Text Key: 120981404
• Report Number: 1950204-2018-00363
• Device Sequence Number: 1
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2018

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: 09/10/2018
• Device Catalogue Number: 21346
• Device Lot Number: 2450288203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 09/13/2018
• Supplement Dates Manufacturer Received: 09/18/2018
• Supplement Dates FDA Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2017
• 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