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, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) contacted biomérieux to report the occurrence of a misidentification of campylobacter species as neisseria cinerea in association with the vitek® 2 neisseria-haemophilus (nh) identification (id) test kit.The customer did not indicate if repeat or confirmatory testing was performed.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to the patient's state of health.Biomérieux requested strain submittal from the customer.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) had contacted biomérieux to report the occurrence of a misidentification of campylobacter species as neisseria cinerea in association with the vitek® 2 neisseria-haemophilus (nh) identification (id) test kit.An internal biomérieux investigation was performed.The customer's strain and raw data were not available.The customer had incubated the isolate at 42c for 48 hours.The nh culture requirements table states the age of culture range is 18-24 hours for campylobacter isolates.Strains tested outside of the recommended culture requirements may give atypical results.The strain was identified by the customer lab as campylobacter species by gram stain morphology and positive campylobacter agglutination testing.One lab report was received.The lab report submitted had an 88% probability of neisseria cinerea with five atypical negative reactions ( odc, pvate, dmlt, lglm, dxyl) for an identification of campylobacter species.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 is not possible to further evaluate the cause of the mis-identification.The vitek 2 nh id card, lot #2450433103, met final qc release criteria.The lot passed 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: jeff scanlan ; 595 anglum road; hazelwood, MO 63042 ; 3147318694
• MDR Report Key: 7774033
• MDR Text Key: 116867253
• Report Number: 1950204-2018-00286
• Device Sequence Number: 1
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (y/n): N
• Reporter Country Code: MK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2018

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: 02/02/2018
• Device Catalogue Number: 21346
• Device Lot Number: 2450433103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 08/10/2018
• Supplement Dates Manufacturer Received: 09/25/2018
• Supplement Dates FDA Received: 10/22/2018
• 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