A customer from (b)(6) notified biomérieux of some strains that initial results were resistant (r) for imipene, ertapeneme, e coli, morganella, and proteus associated with vitek® 2 ast-n233 test kit.Guidance from biomérieux to inspect product packaging, revealed puncture holes in the card foil pack.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.A biomérieux internal investigation has been initiated.
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An internal biomérieux investigation was performed with results as follows: this investigation was initiated in response to a customer complaints reporting holes in the white card pouches of some cards at the stitch seam.The root cause of the defect was linked to the design of the wheel that applies the stitch seal to the pouch.On (b)(6) 2017, stitch wheels with a new design were installed that resolve the issue.Fsca 3445 will be issued, including a customer notification with instructions for inspecting pouches prior to use in order to detect breaches and reduce the likelihood of using cards exposed to moisture.The customer letter will also explain the potential effects of moisture exposure on card performance.
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