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Intended use: the vitek® 2 gram-positive susceptibility card is intended for use with the vitek® 2 systems in clinical laboratories as an in vitro test to determine the susceptibility of staphylococcus spp., enterococcus spp., and s.Agalactiae to antimicrobial agents when used as instructed.Issue description: a customer from spain notified biomérieux of a false susceptibletrimethoprim/sulfamethoxazole (sxt) result for a streptococcus agalactiae patient strain in association with vitek 2 ast-p589 test kit (ref.22279, lot 3692211503, exp date:12/16/2023).This complaint is related to complaint (b)(4) (same patient, same issue, different product: ast-st03 test kit).The two complaints (b)(4) and (b)(4) were created to document ast results obtained with samples from a patient with a finger injury.Patient¿s information: the patient is a woman, 32 years old, that had three (3) surgeries on the wound and has lost most of the finger due to infection.The patient was not responding to treatment and she is allergic to beta-lactam antibiotics and vancomycin, so the treatment options are limited.Patient was treated with cotrimoxazole in (b)(6) and (b)(6) 2022 prior to sending the first sample to the laboratory.The patient was on cycles of cotrimoxazole and linezolid.Information on ast results: in (b)(6), customer analyzed a first sample (swab from the wound) with vitek 2 (ast-p589 test kit - 22279), which reported positive for s.Agalactiae and sensitive for sxt.She begins to be treated with this antibiotic but the infection does not resolve.Between october and february, samples from this patient continue to arrive at the laboratory, including tissue from (2) two interventions that she had to undergo for the infection (they had to remove part of her finger).All reported positive for s.Agalactiae and sensitive for sxt (methods used are unknown).Finally, in february, since the patient did not evolve favorably with the treatment, they did in parallel a test with ast-st03 card (results documented in related complaint (b)(4) , a diffusion disk and etest.Vitek 2 ast result was sensitive and disk diffusion and etest were resistant.At this point customer stopped reporting any cotrimoxazole sensible results for s.Galactiae.Biomérieux field application specialist (fas) repeated the whole process and the results were the same.New samples will be sent to the laboratory as the patient had a third operation on (b)(6) 2023.Results are summarized below: october results : ast-p589 lot # 3692211503: trimetoprima/sulfametoxazol <= 10 s.February results: initial testing (2 -feb-2023) ast-st03, lot# 5422257203: sxt <= 10 s.Incubation aerobic environment e-tests results & diffusion discs: no halo.Repeat testing (fas) ¿ (28-feb-2023) ast-st03, lot# 5422257203: sxt <= 10 s- incubation aerobic environment diffusion discs results : resistant., note: biomérieux global customer service (gcs) notified customer that the recommended incubation atmosphere for st03 testing per the eifu is 5-10% co2.The customers incubation in an aerobic environment is considered off label use.Biomérieux medical affairs department stated in their review: ¿ in this case, it is suspected the treating clinician selected trimethoprim-sulfamethoxazole (sxt) based on ast results showing susceptibility to sxt.The ifu for ast-p589 lists no limitation or requirement to use alternative testing to confirm ast results for this drug.Ultimately, false-susceptibility could have contributed to the continued use of sxt as therapy for this patient¿s infection, and could have contributed to the additional interventions for the patient, including the loss of part of the patient¿s finger.¿ a biomérieux internal investigation will be initiated.
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Context: ********** a customer in spain who encountered false susceptible trimethoprim/sulfamethoxazole (sxt) results when testing multiple isolates of 1 patient strain of streptococcus agalactiae.The strain was tested using ast-p589 lot# 3692211503 and ast-st03 lot# 5422257203.On october, customer analyzed a first sample (swab from the wound) with vitek 2 (ast-p589 test kit 20 cards - 22279), which reported positive for s.Agalactiae and sensitive for sxt.She begins to be treated with this antibiotic but the infection does not resolve.Between october and february, samples from this patient continue to arrive at the laboratory, including tissue from (2) two interventions that she had to undergo for the infection (they had to remove part of her finger).All reported positive for s.Agalactiae and sensitive for sxt (methods used are unknown).Finally, in february, since the patient did not evolve favorably with the treatment, they did in parallel a test with ast-st03 card (results documented in related complaint (b)(4)) , a diffusion disk and etest.Vitek 2 ast result was sensitive and disk diffusion and etest were resistant.** batch history record and complaint trend analysis** there is no capa related to the customer¿s complaint recorded.A complaint history review was completed for this issue concluded with no implication of a trend.This complaint has not been identified as a systemic quality issue.Investigation: *************** **investigation results** the submitted strain was subcultured on cba (cos bmx) medium under co2 for ast-st03 and under aerobic atmosphere for ast-p589 and the identification to streptococcus agalactiae was confirmed on vitek 2 gp cards.The broth micro dilution (bmd) which was the reference method used for trimethoprim/sulfamethoxazole development on ast-st03 card was performed and gave: sxt ref mic > 160 mg/l (> 8/152) r on vitek 2 (aes parameters: copy of global european based + phenotypic), the testing including ast-st03 cards from the customer lot (cl: (b)(4)) and from a random lot (rl: (b)(4)) was performed and gave: sxt vitek 2 mic = 10 mg/l (= 0.5/9.5) s on both lots tested.The vitek 2 sxt mics (= 10 mg/l (= 0.5/9.5) s) are essential agreement errors compared to the reference mic (sxt ref mic > 160 mg/l (> 8/152) r) leading to very major errors of category.The agar dilution (ad) which was the method used for trimethoprim/sulfamethoxazole development on ast-p589 card was performed and gave : sxt ref mic > 640 mg/l (> 32/608) r on vitek 2 (aes parameters: eucast + phenotypic), the testing including ast-p589 cards from the customer lot (cl: (b)(4)) and from a random lot (rl: (b)(4)) was performed and gave: sxt vitek 2 mic = 10 mg/l (= 0.5/9.5) s on both lots tested.The vitek 2 sxt mics (= 10 mg/l (= 0.5/9.5) s) are essential agreement errors compared to the reference mic (sxt ref mic > 640 mg/l (> 32/608) r) leading to very major errors of category.Conclusion: ************* the false susceptible trimethoprim/sulfamethoxazole / streptococcus agalactiae customer¿s results are reproduced in-house with both incriminated cards (ast-st03 and ast-p589).The sxt vitek 2 mics are essential agreements errors compared to the respectively reference mics leading to very major errors of category.The strain presents an unusual growth pattern within the vitek 2 environment.The isolate will be added to the r&d stock collection pending customer approval.Ast-p589, lots 3692211503 (cl) and 3692413203 (rl) met final qc release criteria.The lots passed qc performance testing.
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