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

Catalog Number 21346

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2017

Event Type  malfunction  

Event 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.

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
• Type of Device: VITEK® 2 NH ID TEST KIT
• 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: ellen weltmer ; 595 anglum road; st. louis, MO 63042
• MDR Report Key: 7327526
• MDR Text Key: 102318245
• Report Number: 1950204-2018-00095
• Device Sequence Number: 1
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2018
• Device Catalogue Number: 21346
• Device Lot Number: 2450221203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2018
• Initial Date FDA Received: 03/09/2018
• Supplement Dates Manufacturer Received: 07/24/2018
• Supplement Dates FDA Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2017
• 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