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

Catalog Number	21346
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
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) notified biomérieux of a misidentification associated with vitek®2 nh test kit (reference (b)(4)).The customer reported while testing a strain on the nh card they obtained a low discrimination between actinobacillus urea and h.Influenza species.A subculture was performed and set to the hospital for identification via spectrometry, and the result was neisseria meningitides.Results from the hospital were obtained four (4) days after the first test.There is no known impact to the patient, however there was a delay in reporting results of four (4) days.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
A customer in (b)(6) notified biomérieux of a misidentification associated with vitek®2 nh test kit (reference 21346).The customer reported while testing a strain on the vitek 2 nh card they obtained a low discrimination between actinobacillus urea and h.Influenza species.A subculture was performed and set to the hospital for identification via spectrometry, and the result was neisseria meningitides.An internal biomérieux investigation was performed.The customer reported testing the isolate from a 24 hour culture grown on cos and incubated in co2.Mcfarland of 2.85 was used.No other set up information was provided.The customer indicated the strain was no longer available.One lab report was submitted showing five atypical positive reactions (phos, tyra, phc, ops, ure) for an identification of n.Meningitidis according to the nh knowledge base.Atypical positive reactions can indicate contamination, mixed culture, use of non-recommended media or other user set up errors or an atypical strain; however, without the strain or raw data it's not possible to further evaluate the cause of the misidentification.Vitek 2 nh lot #2450570403 met final qc release criteria.The lot passed initial 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; st. louis MO 63042
• MDR Report Key: 7540800
• Report Number: 1950204-2018-00196
• Device Sequence Number: 19138631
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2018

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 08/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1