A customer in france contacted biomérieux to report the occurrence of false negative patient results for a (b)(6)-year-old female patient in association with the vidas® lyme igg assay (ref.30320).The customer tested two samples from the patient who presented with knee pain for a year.In (b)(6) 2018, she had a loss of sensitivity in the big toe of her left foot.In recent months she has had a loss of sensitivity in her left calf and left cheek.In june, the patient experienced an episode of cephalalgia for one month and was treated with antibiotics.There was no evidence of a tick bite.The samples were tested with several methods and the results were discrepant: sample 1 (ref.7142214) tested on (b)(6) 2019: vidas: negative result (value not reported).Liaison diasorin: positive result (igg = 28 ua/ml).Western blot: positive result (value not reported).Sample 2 (ref.4126342) tested on (b)(6) 2019: vidas: negative result (value not reported).Liaison diasorin: positive result (value not reported).Western blot: positive result (value not reported).Sample 2 (ref.4126342) tested on (b)(6) 2019: vidas: negative result (rfv = 0.18).The samples were sent to the laboratory of "les hospices civils de lyon" and the results were the following: csf sample: liaison diasorin: negative result (value = 0.46).Serum sample: liaison diasorin: positive result (value = 28.75 ua/ml).There is no indication or report from the laboratory or a physician that the discrepant results led to any adverse event related to the patient's state of health.Biomérieux requested strain submittal from the customer.This event has been reviewed for vigilance reporting in accordance with 21 cfr 803, concerning medical device reporting.Biomérieux internal sop 016510 states a false negative result could have a negative influence on the treatment decision as treatment may be incorrectly withheld.This review has determined that this event meets the criteria for reporting as a malfunction.Although this event does not allege that death or serious injury actually occurred, it has been determined that there is potential for serious injury should the situation recur.A biomérieux internal investigation has been initiated.Note: reference 30320 is not registered in the united states.The u.S.Similar device is product reference 417401 (vidas lyme igg ii).
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An internal investigation was performed for a customer report of false negative patient results with vidas® lyme igg (reference 30320, lot 1007253140/ 200324-0).Evaluation of the manufacturing batch records for vidas® lyme igg assay lot 1007253140 showed no anomaly during the manufacturing, control and packaging processes.All the results were within acceptable ranges and vidas lyg batch 1007253140 is compliant to the product specifications.Investigational testing included testing lot 1007253140/ 200324-0 with both internal and patient samples as well as testing with lymechek® optima lgg biosynex®.Vidas lyme igg lot 1007253140/ 200324-0 internal and patient sample results: - internal samples: four internal samples (three positive and one negative) were tested on vidas lyme igg1007253140/ 200324-0.All internal sample results were within specifications and similar to those obtained before the batch release.- customer samples: both patient samples tested using vidas lyme igg batch 1007253140/ 200324-0 obtained positive results.Biomérieux was not able to replicate the customer's results.Lymecheck optima igg biosynex internal and patient sample results: - internal samples: three internal samples tested on vidas lyme igg lot 1007253140/ 200324-0 were also tested on lymecheck optima igg biosynex; all internal samples had the same interpretations as the vidas lyme igg.- customer samples: both customer samples tested obtained equivocal results.The investigation concluded that the vidas® lyme igg assay (lot 1007253140/ 200324-0) is performing as intended.
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