A customer in (b)(6) notified biomérieux of obtaining falsely underestimated results for a patient sample in association with vidas® tsh test kit (ref 30400, batch 1007557590).The customer stated they tested the patient sample twice using the vidas® tsh test kit and obtained results of 0.09 ui/ml and 0.08 ui/ml.The patient sample was also tested using the roche test method at an external laboratory, this test method obtained a result of 1.56 mui/l.The sample was also tested using the siemens test method in a hospital.The value was not reported, the customer reported that the result obtained with siemens method was similar to the result obtained with roche method.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.Biomérieux has initiated an internal investigation.
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An investigation was initiated in response to a customer complaint of obtaining falsely underestimated results for a patient sample in association with vidas® tsh test kit (ref 30400, batch 1007557590).Two samples were submitted by the customer for the investigation.The complaint laboratory performed testing on internal samples as well as the customer's samples with multiple lots including the customer's lot.All test results from internal samples were within specification and did not indicate an issue with the product.Testing the customer's samples reproduced the customer's issue for one sample, but not for the second sample.The investigation concluded that the cause for the falsely underestimated results was not related to a specific lot of product, but rather an interference present in the patient sample.No further investigation into the source of the interference could be completed as there was not enough sample for additional testing.See h10 for addtl mfg narrative.
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