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Model Number 21346
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
This report was initially submitted following notification that a customer in (b)(6) reported the occurrence of a misidentification of (b)(6) (atcc® 19424¿) as neisseria cinerea in association with the vitek® 2 nh identification test kit (card). The customer submitted the (b)(6) (atcc® 19424¿) sample for investigational testing. The investigation included testing of three (3) nh id card lots with the customer strain and the internal biomérieux strain: customer lot 245390220 (cl1) tested twice on both strains. Customer lot 2450185403 (cl2) tested twice on both strains. Random lot 245398920 (rl) tested twice on both strains. Isolates were subcultured as indicated in the package insert. The internal strain (all card lots) obtained identification to (b)(6). The customer strain (all card lots) obtained identification to (b)(6). The investigation did not reproduce the customer results for the customer strain nor the internal reference strain whatever the lot tested. After comparison of biochemical profiles between expected results and the profile obtained by the customer (identification to neisseria cinerea), the investigation observed two (2) discrepant tests (false negative arga and appa). An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain. An increased number of atypical negative reactions may have been caused by leaving the isolate out of co2 for an extended period of time. Since (b)(6) is a fastidious species, it needs to be contained in a co2 environment to retain robustness. If this species is left outside of co2 for extended periods, it will become less robust and therefore less reactive in the nh id card. The investigation concluded the vitek® 2 nh id card is performing as intended.
Event Description
A customer in france notified biomérieux of a discrepant result associated with vitek® 2 nh test kit. The customer performed two methods : they used the strain after 18-24 hours of incubation and after 48 hours of incubation. For each incubation, the results of the atcc strain were non-conforming. The result obtained was neisseria cinerea instead of neisseria (b)(6) the neisseria (b)(6) atcc 19424 has not to be tested systematically with the nh test kit. There is no indication or report from the hospital to biomérieux that the discrepant result led to any adverse event related to a patient's state of health. The strain in question is an internal quality control sample. An internal biomérieux investigation will be initiated.
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Type of DeviceVITEK® 2 NH TEST CARD
Manufacturer (Section D)
595 anglum road
saint louis MO 63042
Manufacturer (Section G)
595 anglum road
saint louis MO 63042
Manufacturer Contact
ellen weltmer
595 anglum road
saint louis, MO 63042
MDR Report Key6489449
MDR Text Key196013137
Report Number1950204-2017-00117
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/20/2017
Device Model Number21346
Device Lot Number245390220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial