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

Catalog Number	21346
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomérieux of discrepant results associated with vitek®2 nh id test kit (reference 21346) lot 2450221203.The customer was testing an rcpa-qap survey sample (8-2017) identified as aggregatibacter aphrophilus, and vitek 2 identified it as actinobacillus pleuropneumoniae.The customer tested the sample multiple times with the following results: (b)(6).The sample used was for quality assurance testing.There was no effect on any patient treatment or condition.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.Vitek 2 nh id test kit, lot 2450221203 was included in fsca 3445.Per the customer, there was no defect found upon inspection.As stated in fsca 3445, cards with intact integrity can be used.An internal biomérieux investigation will be conducted.
Additional Manufacturer Narrative
A customer in (b)(6) notified biomérieux of discrepant results associated with vitek®2 nh id test kit (reference 21346) lot 2450221203.An internal biomérieux investigation was performed.The customer reported setting up the isolate from either ba or choc agar that had been incubated in co2.No other set up information was provided.The customer reported setting up the strain four (4) times with two (2) results of 91% a.Aphrophilus and two (2) low discrimination results of h.Influenzae / a.Pleuropneumoniae and a.Segnis / a.Pleuropneumoniae.One (1) lab report was submitted showing a 91% a.Pleuropneumoniae identification with four (4) atypical reactions (dmal-, nag-, aara-, mte-) for an identification of a.Aphrophilus according to the vitek nh knowledge base.Atypical reactions can indicate contamination, mixed culture, compromised viability of the strain, 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 #2450221203 met final qc release criteria and the lot passed qc performance testing.

• Brand Name: VITEK® 2 NH ID TEST KIT
• Common Device Name: VITEK® 2 NH ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• MDR Report Key: 7327526
• Report Number: 1950204-2018-00095
• Device Sequence Number: 151969
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 08/21/2018

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: 07/05/2018
• Device Catalogue Number: 21346
• Device Lot Number: 2450221203
• 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: 02/08/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1