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| Catalog Number 413117 |
| Device Problem
Low Test Results (2458)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Event Description
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Intended use: the vitek® 2 gram negative susceptibility card is intended for use with the vitek 2 systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic gram-negative bacilli to antimicrobial agents when used as instructed.Issue description: a customer in the united arab emirates notified biomérieux of false susceptible gentamicin and amikacin results for klebsiella pneumoniae isolates in association with the product ast-n233 test kit 20 cards (ref.413117, lot 6331992103, expiration date 11-may-2023) regarding two patients on site 2.This complaint is related to three complaints ((b)(4)) because the same customer reported results from two different customer sites; two (2) patients, k.Pneumoniae isolates, discrepant gentamicin and amikacin results / false s regarding two cards types vitek 2 (ast n215 ¿ lot 6151959503 & ast n233 ¿ lot 6331992103).It was reported false susceptible gentamicin (gm) and amikacin (an) results obtained for k.Pneumoniae isolates using both ast-n215, lot 6151959503 and ast-n233, lot 6331992103.Global summary: ast-n215, lot 6151959503, ast-n233, lot 6331992103.Patient 1 ¿ k.Pneumoniae ssp pneumoniae.Site 1| site 2: vitek 2 instrument a/b n215: gm= =1, s n233: gm
=
1, s | an= 4, s alternative: phoenix ¿ gm= >8, r/ an=>32, r | etest ¿ gm=384, r | an= >256, r.Patient 2 ¿ k.Pneumoniae ssp pneumoniae.Site 1 | site 2: vitek 2 instrument a/b n215: gm= =1, s n233: gm
=
1, s | an= 4, s alternative: phoenix ¿ gm= >8, r/ an=>32, r | etest ¿ gm=128, r | an= >256, r.Note: amikacin is not found on the n215 card.Regarding patient impacts, it was reported that patients show non-response to antimicrobials given including aminoglycosides.Patients may have developed nephrotoxicity, either due to amikacin or their original condition.In this context, as nephrotoxicity can be a life-threatening condition and could be caused by antibiotic usage and/or prior damage to the kidneys due to other (non-antibiotic) causes, additional requests were made to be able to distinguish this possibility with more information about the patient¿s illness and other aspects of his/her health status.The following information have been received from the customer: receipt of intra-veinous amino-glycosides while in intensive critical units (icus), where they were in critical condition due to sepsis along with the patients own comorbidities which all can contribute to undesirable side effects including nephrotoxicity.There is only one associated vitek 2 saline dispensette and no autoclaving is done for this dispensette because previous autoclaving of another dispensette (provided by al hashar ph) resulted in breakage due to autoclaving.Al hashar pharmacy (local distributor) recommended not to autoclave the remaining dispensette the customer depends on saline sterility test.If there is any contamination, then the dispensette is cleaned by alcohol.Note: the only biomérieux approved method of cleaning the dispensette is via autoclave.The use of alcohol can lead to poor growth within the vitek 2 card that has the potential to cause false susceptible results.According to biomérieux medical affairs assessment, in this case there is a potential connection between ast results and treatment, leading to nephrotoxicity.An investigation has been initiated.
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Manufacturer Narrative
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A customer in oman reported false susceptible gentamicin and amikacin results for 2 patient isolates at 2 different sites.The customer¿s isolates were submitted for this investigation.Crm (b)(4) ¿ site 1 (complaint site): ast-n215, lot 6151959503 crm (b)(4) ¿ site 1: ast-n233, lot 6331992103 crm (b)(4) ¿ site 2: ast-n215, lot 6151959503 crm (b)(4) ¿ site 2: ast-n233, lot 6331992103 crm (b)(4) ¿ ast-n417, lot 0192209404 crm (b)(4) ¿ ast-n419, lot 0442119504 crm (b)(4) ¿ ast-n222, lot 6222042203 customer testing summary: *ast-n215 (drug version gm01n, no amikacin on the card), lot 6151959503 ast-n233 (drug versions gm01n, an01n) lot 6331992103 patient 1 ¿ k.Pneumoniae ssp.Pneumoniae, 4151a site 1 | site 2: vitek 2 instrument a/b n215: gm= =1, s n233: gm
=
1, s | an= 4, s n417: lot 0192209404, an=32, i | gm= =1, s (initial and repeat) n222: lot 6222042203, an
=
2, s | gm= =1 alternative: phoenix ¿ gm= >8, r/ an=>32, r | etest ¿ gm=384, r | an= >256, r patient 2 ¿ k.Pneumoniae ssp.Pneumoniae, 4153a site 1 | site 2: vitek 2 instrument a/b n215: gm= =1, s n233: gm= =1, s | an= 4, s n417, lot 0192209404, an=32, i | gm= =1, s (initial and repeat) n419, lot 0442119504, an=32, i | gm
=
1, s n222, lot 6222042203, an
=
2, s | gm= =1 alternative: phoenix ¿ gm= >8, r/ an= >32, r | etest= gm=128, r | an= >256, r the customer has noted these discrepancies are occurring with cre k.Pneumoniae isolates and has tested them using two vitek 2 compact instruments.In addition to testing at the customer site, the isolates were sent to a second site where they were also tested on two vitek 2 compact instruments.The customer confirmed parallel testing was not performed, 4 separate suspensions were created.The testing documented above was all performed on the same day.Gcs did not identify any off-label use regarding setups of both the complaint site and the second site.Regarding dispensette use: the customer stated they used to autoclave dispensette until one was broken in the autoclave.They were advised by al hashar pharmacy (the company who provided the dispensette) to discontinue autoclaving the remaining dispensette.They now depend on saline sterility test to detect contamination and will clean with alcohol if contamination is found.19oct2022: the customer's raw data has been integrated for analysis and can be found exper 1092/essay 517 on the stlrd1 database.20oct2022: r&d customer data analysis: graphs from 1092/517 were analyzed.Data were integrated for 8 replicates.By reviewing barcodes listed on the reports provided, it was determined that no data were integrated for patient 2.For patient 1 data: a) 8 replicates of gm01n were evaluated.The pc well showed growth at ~3 hours for all replicates.For two replicates with results of 2 mg/l, the low concentration well (4) grew at ~4.5 to 5 hours with the remaining replicate¿s low well growing at ~5.5 to 6.5 hours and giving a result of =1 mg/l.B) 4 replicates of an01n were evaluated.The pc well showed growth at ~3 hours with the low concentration well (8) showing growth between ~4.5 ¿ 5 hours giving a result of 4 mg/l for all replicates.Growth seen in graph review is consistent with mics reported.----------------- the customer's submitted strains were subcultured to tsab agar and incubated at 35-37 degrees c for 18-24 hours.Second subcultures were performed, identifications confirmed as klebsiella pneumoniae, and testing included ast-n215 and ast-n233 cards from the customer's lots (6151959503, 6331992103) and random lots (6152034103, 6332076403) in duplicate for each strain.Agar dilution was also performed as the reference testing method used in the development of an01n and gm01n drug versions found in these cards.Additionally, a saline sterility check was performed prior to this internal testing and was negative.Exper/essay 5492/557 bmx stock # 912802 (4151a): >ast-n215 results: gentamicin mics =1, susceptible (x4) >ast-n233 results: amikacin mics =2, susceptible (x3) and mics = 4, susceptible (x1) gentamicin mics =1, susceptible (x4) > reference agar dilution (ad) results: amikacin mic >128, resistant and gentamicin mic >32, resistant bmx stock # 912803 (4153a): >ast-n215 results: gentamicin mics =1, susceptible (x4) >ast-n233 results: amikacin mics =2, susceptible (x2) and mics = 4, susceptible (x2) gentamicin mics =1, susceptible (x4) > reference agar dilution (ad) results: amikacin mic >128, resistant and gentamicin mic >32, resistant in summary, the customer's reported false susceptible results were duplicated with ast-n215 and ast-n233 cards, demonstrating an essential agreement error and a very major category error when compared to the reference testing for the vitek 2.------------------------ ** lcs recommended the customer perform testing using two new cards: ast-n417 and ast-n419 which contains updated drug versions, an03n and gm02n.Note, the customer does not routinely use these two cards, and testing was solely for troubleshooting purposes.Customer's additional testing summary: ast-n417, lot 0192209404 isolate 1: an=32, i | gm= =1, s isolate 2: an=32, i | gm
=
1, s ast-n419, lot 0442119504 isolate 2: an=32, i | gm
=
1, s note the following limitation fda/eucast limitation for an03n: the ability of the ast card to detect resistance with the following combination(s) is unknown because resistant strains were either not available or an insufficient number were encountered at the time of comparative testing: amikacin (an03n): pseudomonas spp., e.Coli, proteus spp.(including p.Mirabilis), klebsiella spp., enterobacter spp., k.(enterobacter) aerogenes, serratia spp., c.Freundii, providencia spp.Biomerieux conducted additional testing using these card types 28dec2022: the customer's submitted strains were subcultured to tsab agar and incubated at 35-37 degrees c for 18-24 hours.Second subcultures were performed and testing included ast-n417 and ast-n419 cards from the customer's lots (0192209404, 0442119504) and random lots (0192306204, 0442215204) in duplicate, as well as broth microdilution (bmd) as the reference testing method used in the development of an03n and gm02n drug versions found in these cards.Additionally, a saline sterility check was performed prior to this internal testing and was negative.Exper/essay 5492/559 bmx stock # 912802 (4151a): >ast-n417 results: amikacin mics = 32, intermediate (x4) gentamicin mics =1, susceptible (x4) >ast-n419 results: amikacin mics = 32, intermediate (x4) gentamicin mics =1, susceptible (x4) > reference broth microdilution (bmd) results: amikacin mic >64, resistant and gentamicin mic >16, resistant bmx stock # 912803 (4153a): >ast-n417 results: amikacin mics = 32, intermediate (x4) gentamicin mics =1, susceptible (x4) >ast-n419 results: amikacin mics = 32, intermediate (x4) gentamicin mics =1, susceptible (x4) > reference broth microdilution (bmd) results: amikacin mic >64, resistant and gentamicin mic >16, resistant in summary, the customer's reported false susceptible gentamicin results were duplicated with ast-n417 and ast-n419 cards, demonstrating an essential agreement error and a very major category error when compared to the reference testing for the vitek 2.The customer's false intermediate amikacin results were also duplicated, demonstrating an essential agreement error and a minor category error when compared to the reference testing for the vitek 2.This investigation will not be elevated to an expertise investigation because of the uncharacteristic growth pattern of two strains relative to the vitek 2 (an01n, an03n) and (gm01n, gm02n) ast knowledge base and there is no implication of a systemic quality issues related to amikacin, gentamicin, or the lots in question.Global customer service (gcs) queried trackwise (tw) and trackwise digital (twd) for false susceptible complaints coded gm, an, mult when testing k.Pneumoniae from 08nov2021 to 09dec2022 returning nine complaints with four coded for investigation and all associated with this investigation.The remaining complaints that were not coded for investigation were closed with routine troubleshooting.No capas were opened for this performance issue during the same time frame.Gcs performed a tw and twd search for all complaints against ast-n215 card lots 6151959503 and 6152034103 returning two and no complaints respectively (both associated with this investigation), and no indication of a trend.Gcs performed a tw and twd search for all complaints against ast-n233 card lots 6331992103 and 6332076403 returning five and one complaint respectively.A review of these returned complaints did not indicate a trend for these card lots.Gcs performed a tw and twd search for all complaints against ast-n417 card lots 0192209404 and 0192306204 returning one and no complaints, respectively, and no indication of a trend.Gcs performed a tw and twd search for all complaints against ast-n419 card lots 0442119504 and 0442215204 returning one and no complaints, respectively, and no indication of a trend.Ast-n215, lots 6151959503 (cl) and 6152034103 (rl) met final qc release criteria.The lots passed qc performance testing.Nc 1768729 was written against lot 6151959503 for issues unrelated to the issue under investigation (tor not exceeding allowable thresholds).Nc 1766455 written against lot 6152034103 for issues unrelated to the issue under investigation (cosmetic tear tape issue not impacting card performance).Ncmrs and ncs were reviewed for the last 13 months (28oct2021 to 28nov2022).No ncmrs or ncs were written for the n215 cards for performance issues related to the issue under investigation.Ast-n233, lots 6331992103 (cl) and 6332076403 (rl) met final qc release criteria.The lots passed qc performance testing.Nc 1768729 was written against lot 6331992103 for issues unrelated to the issue under investigation (tor not exceeding allowable thresholds).Nc 1768991 written against lot 6332076403 for issues unrelated to the issue under investigation (tear tape addressed with lot rework before being released inventory).Ncmrs and ncs were reviewed for the last 13 months (28oct2021 to 28nov2022).No ncmrs or ncs were written for the n233 cards for performance issues related to the issue under investigation.Ast-n417, lots 0192209404 and 0192306204 met final qc release criteria.The lots passed qc performance testing.Ncmrs and ncs were reviewed for the last 13 months (28oct2022 to 28nov2022).No ncmrs or ncs were written for the ast-n417 cards for performance issues related to this investigation.Ast-n419, lots 0442119504 and 0442215204 met final qc release criteria.The lots passed qc performance testing.Ncmrs and ncs were reviewed for the last 13 months (28oct2022 to 28nov2022).No ncmrs or ncs were written for the ast-n419 cards for performance issues related to this investigation.
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Event Description
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Intended use: the vitek® 2 gram negative susceptibility card is intended for use with the vitek 2 systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic gram-negative bacilli to antimicrobial agents when used as instructed.Issue description: a customer in the united arab emirates notified biomérieux of false susceptible gentamicin and amikacin results for klebsiella pneumoniae isolates in association with the product ast-n233 test kit 20 cards (ref.413117, lot 6331992103, expiration date 11-may-2023) regarding two patients on site 2.This complaint is related to three complaints (b)(4) because the same customer reported results from two different customer sites; - two (2) patients, - k.Pneumoniae isolates, - discrepant gentamicin and amikacin results / false s - regarding two cards types vitek 2 (ast n215 ¿ lot 6151959503 & ast n233 ¿ lot 6331992103).It was reported false susceptible gentamicin (gm) and amikacin (an) results obtained for k.Pneumoniae isolates using both ast-n215, lot 6151959503 and ast-n233, lot 6331992103.Global summary: *ast-n215, lot 6151959503.Ast-n233, lot 6331992103.Patient 1 ¿ k.Pneumoniae ssp pneumoniae.Site 1| site 2: vitek 2 instrument a/b.N215: gm= =1, s.N233: gm
=
1, s | an= 4, s.Alternative: phoenix ¿ gm= >8, r/ an=>32, r | etest ¿ gm=384, r | an= >256, r.Patient 2 ¿ k.Pneumoniae ssp pneumoniae.Site 1 | site 2: vitek 2 instrument a/b.N215: gm= =1, s.N233: gm
=
1, s | an= 4, s.Alternative: phoenix ¿ gm= >8, r/ an=>32, r | etest ¿ gm=128, r | an= >256, r *note: amikacin is not found on the n215 card.Regarding patient impacts, it was reported that patients show non-response to antimicrobials given including aminoglycosides.Patients may have developed nephrotoxicity, either due to amikacin or their original condition.In this context, as nephrotoxicity can be a life-threatening condition and could be caused by antibiotic usage and/or prior damage to the kidneys due to other (non-antibiotic) causes, additional requests were made to be able to distinguish this possibility with more information about the patient¿s illness and other aspects of his/her health status.The following information have been received from the customer: - receipt of intra-veinous amino-glycosides while in intensive critical units (icus), where they were in critical condition due to sepsis along with the patients own comorbidities which all can contribute to undesirable side effects including nephrotoxicity.- there is only one associated vitek 2 saline dispensette and no autoclaving is done for this dispensette because previous autoclaving of another dispensette (provided by al hashar ph) resulted in breakage due to autoclaving.Al hashar pharmacy (local distributor) recommended not to autoclave the remaining dispensette the customer depends on saline sterility test.If there is any contamination, then the dispensette is cleaned by alcohol.Note: the only biomérieux approved method of cleaning the dispensette is via autoclave.The use of alcohol can lead to poor growth within the vitek 2 card that has the potential to cause false susceptible results.According to biomérieux medical affairs assessment, in this case there is a potential connection between ast results and treatment, leading to nephrotoxicity.An investigation has been initiated.
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