A customer in (b)(6) notified biomérieux of the false detection of carbapenemase phenotype, due to false resistant imipenem and meropenem (mics for both >=16), for escherichia coli in association with the vitek® 2 ast-n263 test kit (ref.413755, lot 6631115203).The customer stated initial testing with an 18-hour culture indicated carbapenemase suspected (imipenem and meropenem resistant), advanced expert system¿ (aes) consistent, therapeutic corrections made by aes for cephalosporines.The customer performed retesting with same culture plate at 28-hours (non-compliant with instructions for use); obtained consistent aes report, without therapeutic corrections, and no carbapenemase warning (imipenem and meropenem both susceptible at mic =<0.25).Testing via alternative method (method used not disclosed by the customer) resulted in negative for carbapenemase.The customer stated there was no impact on the treatment decision; there was no adverse impact to the patient's state of health.A biomérieux internal investigation was initiated in response to this customer complaint.Please note: during a retrospective review of vitek 2 mdr submissions it was determined that this imipenem malfunction was not reported to fda.The associated complaint was received by biomerieux on 12 sep 2019 and was assessed for reportability within thirty days.Mdr 1950204-2019-00298 was submitted to fda on 08 oct 2019 for a meropenem malfunction reported in the same complaint.Biomerieux apologizes for the mdr omission and we wish to ensure full transparency of reportable events, hence we are submitting this mdr.There was no patient injury associated with this malfunction.
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