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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GN ID TEST KIT

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BIOMERIEUX, INC VITEK® 2 GN ID TEST KIT Back to Search Results
Catalog Number 21341
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Biomérieux internal investigations were conducted for events #4 through #9. For events #1 through #3 and events #10 through #12, investigation results are pending. Event #4: the strain was identified as escherichia coli by 16s rrna sequencing. Three (3) lab reports were submitted by the customer for review. The isolate was not submitted. The customer tested the isolate from macconkey agar. The age of culture is unknown. A review of the submitted lab reports indicates the following atypical reactions for escherichia coli in the vitek 2 gram-negative knowledge base. (b)(6). As the customer did not comply with biomérieux's request for isolate submittal, no investigational testing is possible. Escherichia coli and shigella are closely related species. Any identification of shigella should be confirmed by another method such as serology. The gn id lab report prints the message "confirm by serological tests" for any identification of shigella. In this case the customer acted in accordance with product labeling and performed molecular testing which confirmed the identification as escherichia coli. Event #5: per vitek 2 product information manual, citrobacter werkmanii is not on the vitek 2 gn id database. Biomérieux requested submittal of the patient isolate for internal testing, however the customer indicated the isolate was no longer available. When an isolate is tested in the gram-negative (gn) card, it will attempt to match the reactions to known biopatterns stored in the knowledge database. If the reaction pattern of an unclaimed species is tested and match those in the knowledge database with a high degree of confidence, then a misidentification can occur. In conclusion, the vitek 2 product information contains the following warning located in the "limitations" section: "testing of an unclaimed species may result in an unidentified result or misidentification". Event #6: the customer tested the isolate from gcg agar (becton-dickinson), which is not a validated media for the vitek 2 gn id card. Testing of the isolate submitted by the customer included inoculation and incubation on cba media, vitek ms identification to escherichia coli, vitek 2 gn id (customer lot and random lot) identification to escherichia coli. The investigation did not duplicate the misidentification obtained by the customer. The biochemical profile for the results obtained internally indicates six (6) additional positive tests (proa, ilatk, ellm, ggt, agal, phos) as compared to the biochemical profile on the customer lab report. The investigation concluded the vitek 2 gn id cards are performing as intended. Event #7: four (4) lab reports were submitted by the customer. Set up information, strain or raw data were not provided. One (1) report showed an identification of salmonella enterica ssp diarizonae with one (1) atypical reaction (h2s) for e. Coli according to the gram-negative (gn) knowledge base. Three (3) reports showed an identification of shigella sonnei. Review of the atypical reactions did not reveal any according to the gram-negative (gn) knowledge base; however, the hour of call was early (4-4. 75 hours) and many reactions are not finalized at this point. E. Coli is closely related to both salmonella and shigella. Any identification of either salmonella or shigella should be confirmed with another testing method such as serology. The gram-negative (gn) lab report prints the message "confirm by serological tests" for any identification of salmonella or shigella. The customer reported that the organism was identified using another method. Event #8: a strain of burkholderia cepacia was submitted for vitek 2 evaluation because the gn card gave calls of acinetobacter ursingii or acinetobacter baumannii complex; however, pcr gave an identification of burkholderia cepacia. The organism also grew on b cepacia media. Two (2) slants were submitted with two (2) different numbers, but only lab reports for one was included. The isolates were subcultured and testing included two (2) gn cards of the same lot as that tested by the customer and two (2) cards from a random lot. Also performed was the ap 20ne, 16s sequencing and the vitek ms. Isolate, 911139 (25650): the four (4) gn cards gave calls of acinetobacter baumannii complex. Isolate 911140 (703287): gave calls of acinetobacter ursingii from three (3) gn cards and an excellent identification call of bordetella hinzii from the fourth gn card. For both isolates: the api 20ne was completely nonreactive after 48 hours of incubation. Sequencing was only able to determine it to be a burkholderia species. Vitek ms was performed and no identification was obtained for 911139 and for 911140, a low discrimination call between burkholderia vietnamiensis/burkholderia cepacia was obtained. Review of the customer and internal data show the organism to be very nonreactive in the gn cards. It was also nonreactive in the api 20ne after 48 hours of incubation and the vitek ms for one was only able to give a low discrimination call. This is a gram negative rod that internal testing was unable to definitively determine the identification. Root cause: atypical strain based upon multiple testing methods to include vitek 2, api 2one, 16s sequencing and vitek ms. Event #9: testing of the organism included two (2) gn cards from the same lot as that tested by the customer, two (2) cards from random gn lots, and the api 20e. All four (4) gn cards tested gave low discrimination calls of e. Coli/s. Sonnei. Api 20 e gave a good identification (96. 3%) of e. Coli. Therefore, the final identification of this organism is e. Coli. Since the gn cards also gave e. Coli as a possible identification for this organism, the vitek 2 results are correct. It should be noted that, when an identification of s. Sonnei is made by gn cards, an analysis message of "confirm by serological tests" is given. A review of the customer gn card reaction results against the expected results for e. Coli revealed 3 atypical negative reactions (dsor, phos, ldc) that led to the misidentification. The vitek 2 gn test kits are performing as expected and no further action is necessary.
 
Event Description
This report summarizes 12 malfunction events. (b)(4). A review of events indicated that testing via vitek 2 gram negative (gn) identification test kit resulted in misidentifications to include: misidentification of shigella sonnei instead of escherichia coli involving a patient sample. Misidentification of alcaligenes faecalis instead of acinetobacter baumannii involving a patient sample. Misidentification of yersinia pestis instead of rosenbergiella australoborealis involving a patient sample. Misidentification of shigella sonnei instead of escherichia coli involving a patient sample. Misidentification of citrobacter farmeri instead of citrobacter werkmanii involving a patient sample. Misidentification of salmonella enterica instead of escherichia coli involving a patient sample. Misidentification of salmonella or shigella instead of escherichia coli involving a patient sample misidentification of acinetobacter instead of burkholderia cepacia involving a patient sample. Misidentification of shigella sonnei instead of escherichia coli involving a patient sample. Misidentification of shigella instead of escherichia coli involving a patient sample. Misidentification of proteus mirabilis instead of morganella morganii involving a patient sample. Misidentification of raoultella planticola instead of klebsiella oxytoca involving a patient sample. For all 12, there was no indication or report of adverse events or negative patient due to the discrepant results.
 
Manufacturer Narrative
This report was initially submitted 26-jul-2016 as part of the (b)(4) pilot program (exemption number (b)(4)) for a vitek® 2 gn id misidentification of klebsiella oxytoca as raoultella planticola. Biomérieux investigation was conducted. The isolate was subcultured and testing included two (2) vitek® 2 gn id cards from the same lot tested by the customer, two (2) cards from a random lot, the api® 20e and 16s sequencing. The four (4) vitek® 2 gn id cards gave excellent identification calls of raoultella planticola. Sixteen (16)s sequencing identified the organism to klebsiella species. Api® 20e identified the strain as klebsiella oxytoca. Review of the raoultella planticola data against the expected reactions for klebsiella oxytoca show there to be two (2) atypical positive reactions (bnag, naga) that contributed to the misidentification. The investigation concluded this is an atypical strain for the vitek® 2 gn knowledge base.
 
Manufacturer Narrative
This report was initially submitted 26-jul-2016 as part of the 227 pilot program (exemption number (b)(4)). A customer in the united states contacted biomérieux to report a misidentification of escherichia coli as shigella sonnei in association with the vitek® 2 gn id test kit. The result was reported to the physician. In addition, the patient isolate was sent to the state laboratory for testing; the result obtained was escherichia coli. The isolate was retested via vitek® 2 gn id test kit and the result was shigella sonnei. There is no report from the hospital or treating physician that the occurrence lead to any adverse event related to the patient's state of health. Biomérieux requested culture submittal from the customer. Upon receipt of the submittal (two isolates from the same patient), internal investigation was conducted. Isolate 1 (collected (b)(6)): · vitek® 2 gn id (customer lot) - shigella sonnei · vitek® 2 gn id (random lot) - shigella sonnei · api 20e® - escherichia coli, inactive. Isolate 2 (collected (b)(6)): · vitek® 2 gn id (customer lot) - shigella sonnei · vitek® 2 gn id (random lot) - shigella sonnei · api 20e® - escherichia coli, inactive. Escherichia coli and shigella are closely related species. Per the instructions for use (ifu), any identification of shigella should be confirmed by another method such as serology. The gn id lab report prints the message "confirm by serological tests" for any identification of shigella. In this case the customer acted in accordance with product labeling and performed confirmatory testing. The investigation concluded this is an atypical strain for the vitek® 2 gn knowledge base.
 
Manufacturer Narrative
This report was initially submitted 26-jul-2016 as part of the (b)(6) program (b)(4). Biomérieux investigation was conducted. The customer's lot of gn id card was not available; two random lots were tested. Investigational testing included: vitek® 2 gn id (random lot #1): low discrimination between escherichia coli / shigella group. Vitek® 2 gn id (random lot #2): low discrimination between shigella group / shigella sonnei. Id32e strip: obtained result of escherichia coli. Api® 50che strip: obtained result of escherichia coli. Api® 20e strip: obtained result of escherichia coli. Vitek® ms: obtained result of escherichia coli. The reported misidentification was reproduced with vitek® 2 gn id random lot #2. Escherichia coli and shigella are closely related species. Per the instructions for use (ifu), any identification of shigella should be confirmed by another method such as serology. The gn id lab report prints the message "confirm by serological tests" for any identification of shigella. In this case, the customer acted in accordance with product labeling and performed confirmatory testing. The investigation concluded this is an atypical strain for the vitek® 2 gn knowledge base.
 
Manufacturer Narrative
An investigation into a mis-identification event while using the vitek 2 gn id test kit was performed. A gram negative rod was submitted for vitek 2 evaluation because the customer stated the gn card gave identification of proteus mirabilis, however alternate biotype testing identified the strain as morganella morganii. Testing of the isolate included 2 gn cards from the same lot tested by the customer, 2 cards from a random lot and the api 20e. The four gn cards gave excellent identification of proteus mirabilis and the api 20e identification of morganella morganii with a 99. 9% confidence level, confirming the gn card to have misidentified the organism. Review of the proteus mirabilis data against expected reactions for morganella morganii show there to be 1 atypical positive reaction contributing to the misidentification. A complaint history review was completed for this issue during the last 13 month timeframe with no implication of a trend. No further action required. This is an atypical strain. Based on the results of the investigation, the product is operating within specifications.
 
Manufacturer Narrative
A customer in (b)(6) notified biomérieux of a misidentification of rosenbergiella australoborealis as yersinia pestis in association with the vitek 2 gn test kit (ref 21341). An internal biomérieux investigation was performed. The customer tested the isolate from tsab (oxoid) using a 24 hour culture incubated in co2 at 37c. The isolate was tested three (3) times in the gn card and each time the gn card reported yersinia pestis. In addition, the customer reported using another system (microbatt), which identified the organism as an atypical enterobacteriaceae; however, when they tried an isolated colony using the vitek ms it gave no identification (id). Rosenbergiella australoborealis is not in the gn knowledge base. The product labeling has a limitation stating that testing of unclaimed species may result in erroneous or misidentification. The gn lots 241373440 and 241356140 met final qc release criteria.
 
Manufacturer Narrative
An internal biomérieux investigation was conducted for a misidentification in association with the vitek® 2 gn test kit. The customer submitted two (2) lab reports which were reviewed. Both reports showed an excellent identification of alcaligenes faecalis ssp faecalis, and displayed four (4) atypical negative reactions (dcel, dglu, dmne, o129r) for an identification of acinetobacter baumannii according to the vitek® 2 gn knowledge base. 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's not possible to further evaluate the cause of the misidentification. A review of quality control records showed gn lot 241376740 met final release criteria and no misidentification issues were observed on initial qc performance testing. The investigation concluded that the vitek® 2 gn test kit is performing as intended.
 
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Brand NameVITEK® 2 GN ID TEST KIT
Type of DeviceVITEK® 2 GN ID TEST KIT
Manufacturer (Section D)
BIOMERIEUX, INC
595 anglum road
st. louis MO 63042
Manufacturer (Section G)
BIOMERIEUX, INC
595 anglum road
st. louis MO 63042
Manufacturer Contact
ellen weltmer
595 anglum road
hazelwood, MO 63042
3147317301
MDR Report Key5828867
MDR Text Key50625286
Report Number1950204-2016-00072
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
CL. I EXEMPT
Number of Events Reported12
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/01/2017
Device Catalogue Number21341
Device Lot Number241376140
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 Received01/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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