MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT; VITEK® 2 GP ID CARD

Catalog Number 21342

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Biomérieux internal investigations were conducted for events #1 through #5, #7 through #11 and #14.For events #6, #12 and #13, investigation results are pending.Event #1: investigational testing performed with in-house cnq (b)(6) strain: api 20 strep: no identification obtained at 4 hours nor 24 hours of incubation rapid id32 strep: obtained identification of enterococcus gallinarum vitek 2 gp id: obtained identification of enterococcus faecium vitek ms: obtained identification of enterococcus faecium the investigation did not duplicate the customer result of enterococcus gallinarum.Conclusion: vitek 2 gp id cards are performing as expected.Event #2: testing included: - sequencing (soda): identification to the species streptococcus anginosus.- vitek 2 gp id (two customer lots and one random lot): identification to streptococcus sanguinis, or low discrimination between streptococcus anginosus and streptococcus sanguinis.- vitek ms: identification to the species streptococcus anginosus.- api 20strep: identification to the species streptococcus anginosus.- rapid id 32 strep: identification to the species streptococcus anginosus.Conclusion: the (b)(6) strain is an atypical strain for vitek 2 system rapid phenotypic ast testing method.Genetic measurement techniques (sequencing and mass spec) and non-automated methods such as api and disc diffusion are more conducive to testing organisms exhibiting this behavior.Event #3: the strain was tested from blood agar, chocolate agar and cps chrom vre.The vitek 2 software version was not provided from the customer.Two lab reports were reviewed and indicated the following atypical reactions for e.Faecium according to the gp knowledge base: lab report (b)(6) 2016: 1 atypical reaction (amy+), lab report (b)(6) 2016: 2 atypical reactions (amy+, alaa+).Conclusion: the cause of the atypical reactions cannot be further evaluated without the strain and/or raw data.Event #4: three (3) strains, but only one was a streptococcus strain (staphylococcus and micrococcus) was received from the customer.The intended result was confirmed on vitek ms: streptococcus suis.The isolate was subcultured on cba and tested on the customer lot (242381910) and on a random lot of gp cards on vitek 2 v7.01.Results: an excellent identification to the species streptococcus suis or a low discrimination including the species streptococcus suis on the two (2) lots tested.Conclusion: the misidentification obtained by the customer on vitek 2 was not duplicated.Vitek® 2 gp cards performed as intended and no further action is required.Event #5: intended result was confirmed on vitek ms: staphylococcus aureus.-isolate was subcultured on cba tested on the two (2) customer lots (242382510-242381940) and on a random lot (242366740) of gp cards on vitek 2 v7.01.Obtained an excellent identification to the species staphylococcus aureus 99% on the 3 lots tested.- after comparison of biochemical profiles: observed 9 different test results between customer and in-house lab reports.- no duplication of the misidentification obtained by the customer as staphylococcus lentus on vitek 2.Conclusion: vitek 2 gp cards determined to be performing as intended.Event #7: the customer submitted a screenshot of the gram-positive (gp) card results.The customer did not state how they verified the identification of e.Faecium.There were two (2) atypical positive results, alaa and draf, for e.Faecium according to the (gp) knowledge base.Conclusion: without the strain or raw data it has been determined not possible to further evaluate the cause of the misidentification.Event #8: the following confirmation(s) for strain (b)(6) are as follows: - on the ctcb qc survey, strain (b)(6), the identification of gemella haemolysans was confirmed with the vitek ms and r id32strep strip.- confirmation utilizing gram-positive (gp) cards, from two (2) different lots, yielded a low discrimination between gemella haemolysans and gemella sanguinis.Complimentary mannitol test indicated by vitek 2 was negative on the r id32strep; therefore, the organism identified was in favor of gemella haemolysans.Conclusion: the misidentification reported by the customer could not duplicated using the vitek (2) gram-positive (gp) test kit.The biochemical profile obtained in house was different for 14 tests.It has been determined that the vitek 2 gram-positive (gp) card is performing as expected.Event #9: the customer set up the vitek 2 gp card from a 24-hour culture grown on columbia sheep blood agar.No additional information was provided as to whether the customer performed additional testing to determine if the vitek 2 gp card or the rapid id 32 strep identification was correct.Vitek 2 gp card results indicated 2 atypical reactions (dman-, sac-) for an identification of a.Urinae.Conclusion: without the strain, it is not possible to do further testing to determine if the gp card result was incorrect.Event #10: the customer repeated the gp testing after obtaining the expected results from cap of leuconostoc mesenteroides ssp mesenteroides or leuconostoc species.The repeat testing was performed on gp lot 242388440 and an excellent identification call of leuconostoc mesenteroides ssp mesenteroides was obtained.In addition to the customer's cap strain, a lyophilized cap sample was reconstituted and tested.The customer's strain and the reconstituted sample were subcultured and gp testing included two (2) cards from the two (2) lots tested by the customer and two (2) cards from a random lot.Each isolate was tested on a total of six (6) gp cards and all gave excellent identification calls of leuconostoc mesenteroides ssp mesenteroides.The lab report for the aerococcus call was not included with the information provided, so it was not possible to determine what may have occurred that resulted in the misidentification.Conclusion: the vitek 2 gp test cards are performing as expected and no further action is required.Event #11: no lab reports, raw data, or strain were submitted.No information was provided for the lot number, software version or set up procedure.The gp knowledge base contains five (5) tests which differentiate between s.Aureus and s.Lentus (amy, aglu, polyb, draf, adh2s).Conclusion: without the strain, lab report or raw data, it is not possible to further evaluate the cause of the misidentification.Event #14: the isolate was tested from chromid (b)(6) with age of culture = 24hrs.The lab report showed 5 atypical positive reactions (pyra, drib, nag, dman, dtre) for s.Epidermidis according to the gp knowledge base.An increased number of atypical positive reactions can indicate contamination, mixed culture, use of non-recommended media or other user set up errors or an atypical strain.Conclusion: without the strain or raw data it's not possible to further evaluate the cause of the misidentification.In addition, follow-up information was received for an initial case reported via the q1 pilot program summary report.Results are as follows: follow-up event: misidentification of streptococcus pneumoniae as kocuria kristinae.Customer lab reports were submitted as photos - vitek 2 software version, reference method used to identify the strains as streptococcus pneumonia and set up details were not provided.(b)(6) lab report showed 13 atypical negative reactions for s.Pneumoniae (bgal, aglu, leua, alaa, tyra, polyb, dgal, lac, nag, dmal, dmne, sac, dtre).(b)(6) lab report showed 12 atypical negative reactions for s.Pneumoniae (bgal, aglu, bgar, agal, polyb, dgal, lac, nag, dmal, dmne, sac, dtre).(b)(6) lab report showed 6 atypical reactions for s.Pneumoniae.Five (5) were atypical negative and 1 atypical positive (aglu, bgar, leua, dmal, dmne all negative, nc6.5 was positive).(b)(6) lab report showed 11 atypical reactions for s.Pneumoniae.Ten (10) were atypical negative and 1 atypical positive (bgal, aglu, bgar, agal, dgal, nag, dmal, dmne, sac, dtre all negative; nc6.5 was positive).Conclusion: without the strain or raw data it is not possible to further evaluate the cause of the misidentification.

Event Description

This report summarizes 14 malfunction events.(b)(4) a review of events indicated that testing via vitek 2 gram positive (gp) identification test kit resulted in misidentifications to include: misidentification of enterococcus gallinarum instead of enterococcus faecium involving a quality control sample.Misidentification of streptococcus sanguinis instead of streptococcus anginosus involving a quality control sample.Misidentification of enterococcus gallinarum instead of enterococcus faecium involving a quality control sample.Misidentification of streptococcus thoraltensis instead of streptococcus sius i, streptococcus sius ii and streptococcus sanguinis involving an animal sample.Misidentification of staphylococcus lentus instead of staphylococcus aureus involving a patient sample.Misidentification of pediococcus pentosaceus instead of streptococcus agalactiae involving a patient sample.Misidentification of enterococcus gallinarum instead of enterococcus faecium involving a patient sample.Misidentification of streptococcus agalactiae instead of gemella haemolysans involving a quality control sample.Misidentification of granulicatella adiacens instead of aerococcus urinae involving a patient sample.Misidentification of aerococcus viridans instead of leuconostoc involving a quality control sample.Misidentification of staphylococcus lentus instead of staphylococcus aureus involving a patient sample.Misidentification of listeria innocua instead of listeria monocytogenes involving a quality control sample.Misidentification of staphylococcus saprophyticus involving a patient sample; however, it was determined to be novobiocin sensitive.Misidentification of staphylococcus aureus/staphylococcus pseudointermedius instead of staphylococcus epidermidis involving a patient sample for all 14, there was no indication or report of adverse events or negative patient impact due to the discrepant results.In addition, follow-up information was received for a vitek 2 gp test kit event initially reported via the pilot program q1 summary.

Manufacturer Narrative

Initial assessment of this report was performed under fda pilot 227 exemption number (b)(4) (submitted as part of the q2 pilot summary report 1950204-2016-00070).This report was initially submitted following notification that a customer in france reported the occurrence of a misidentification of streptococcus agalactiae as pediococcus pentosaceus for a patient isolate in association with the vitek® 2 gram-positive (gp) identification (id) test kit.Biomérieux investigation was conducted; however, the organism and raw test data were not submitted by the customer.The laboratory reports from the customer testing were reviewed.When tested by the customer from cpse media, the identification result was 95% pediococcus pentosaceus.There were three (3) atypical negative reactions (aglu, phos, leua).Cpse agar is a non-recommended media for use with vitek® 2 gp id testing.When testing was repeated from cos media, the identification result was 95% streptococcus agalactiae.There was no information provided as to how the customer determined the correct organism identification was streptococcus agalactiae.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.In this case, there is a discrepancy when the isolate is tested from two different media types.Without the strain or raw data, it's not possible to further evaluate the cause of the misidentification.Evaluation of the manufacturing qc records for vitek® 2 gp id lot 242386110 indicated the lot passed on initial qc performance testing.There were no issues observed on initial qc performance testing.Without the customer strain to test against the reference method, there is no evidence to indicate the vitek® 2 gp id test kit is performing outside of specifications.Device not returned to manufacturer.

Manufacturer Narrative

Initial assessment of this report was performed under fda (b)(4) (submitted as part of the q2 pilot summary report 1950204-2016-00070).This report was initially submitted following notification that a customer in (b)(6) reported the occurrence of a misidentification of atcc listeria monocytogenes as listeria innocua in association with the vitek 2 gram-positive (gp) identification (id) test kit.Biomérieux investigation was conducted.The atcc strain submitted by the customer was tested in parallel with the internal reference strain subcultured on cba plates.The investigation observed two types of colony growth, beta-hemolytic and non-beta-hemolytic isolates.This heterogenous aspect is indicated on the atcc site.The investigation performed testing with each colony type and with combined colony types (customer strain).Vitek ms: identification to listeria monocytogenes, the intended result.Api listeria: identification to listeria monocytogenes.Vitek 2 gp id (customer lot): beta-hemolytic colony - listeria monocytogenes.Non-hemolytic colony - listeria innocua.Combined - listeria innocua.Vitek 2 gp id (random lot): beta-hemolytic colony - listeria monocytogenes.Non-hemolytic colony - listeria innocua.Combined - listeria innocua.The genus listeria monocytogenes and listeria innocua are very close.A comparison of profiles demonstrated the only test that separates these two genus is the piplc test.In case of non-beta-hemolytic colonies, the investigation obtained a negative piplc test due to a loss of virulence factors leading to a result in favor of listeria innocua.The atcc strain contains a non-hemolytic organism that is atypical for the vitek 2 gram-positive knowledge base.Device not returned to manufacturer.

Manufacturer Narrative

This report was initially submitted in response to a customer in (b)(6) reporting the vitek® 2 gp card misidentified a coagulase negative staphylococci as staphylococcus saprophyticus.The customer performed a novobiocin test which was sensitive indicating the id of staphylococcus saprophyticus was incorrect.A second gp id card was tested and the result was staphylococcus hominis ssp hominis which the customer feels is correct.Biomérieux investigation was conducted.The lab report showed a 98% staphylococcus saprophyticus identification with five (5) atypical reactions according to the gp knowledge base for an identification of staphylococcus hominis ssp hominis.It's not possible to fully evaluate this issue without knowing the true reference identification for this strain and without the strain and raw data.An increased number of atypical positive reactions can indicate contamination, mixed culture, use of non recommended media or other user set up errors or an atypical strain.A complaint history review was performed for this issue during the last 13 month timeframe with no implication of a trend.The most recent quarterly trend review did not identify this complaint as a systemic quality issue.Evaluation of the manufacturing qc batch records indicate gp lot 242362910 met final qc release criteria.There were no issues observed on initial qc performance testing.There was no ncmr issued for this lot.Ncmr's were reviewed for the last 13 months and there were no ncmr written for misidentifications.The investigation concluded there is no evidence to suggest the vitek® 2 gp card is performing outside of specifications.Device not returned to manufacturer.

• Brand Name: VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 GP ID CARD
• 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 Key: 5828866
• MDR Text Key: 50630982
• Report Number: 1950204-2016-00070
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K952095
• Number of Events Reported: 14
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2016
• Device Catalogue Number: 21342
• Device Lot Number: 242362910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2016
• 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