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

Catalog Number	21346
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: VITEK® 2 NH ID CARD
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• MDR Report Key: 7774033
• Report Number: 1950204-2018-00286
• Device Sequence Number: 1966959
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (Y/N): N
• Initial Reporter Country: MK
• PMA/510(K) Number: CL. I 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): 10/22/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2018
• Device Catalogue Number: 21346
• Device Lot Number: 2450433103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1