[4495015]
Biomerieux was contacted by (b)(6), to report a discrepant ceftazidime result (false resistant) for acinetobacter baumanii on the bitek 2 ast-n240 test kit. The result provided by the vitek 2 was ceftazidime mic=8 mg/l (i). Confirmation via etest method indicated ceftazidime mic=4 mg/l (s). Prior to reporting results to the treating physician, the patient sample was tested on the vitek 2 and confirmatory test was completed via etest. The discrepant vitek 2 result was not reported to the treating physician; however, there was a 24 hour delay in reporting the result to the treating physician since testing was confirmed via alternate method. The customer indicated it is normal routine for their laboratory to verify the ceftazidime result with etest prior to reporting the ast result; therefore, the clinician made no therapeutic decision based on the bitek 2 ast result. The customer states there was no adverse impact to the patient's state of health. There was a 24-hour delay (48 hours instead of 24 hours) in reporting the result to the clinician. The customer indicates the patient was placed on augmentin/dalacin/gentamycin prior to testing. Treatment was modified to only augmentin after the test result was reported to the treating physician; dalacin and gentamycin were removed. The customer indicated that although reporting of the result was delayed by 24 hours, there was no adverse impact to the patient. Based on the details provided by the customer, there is no evidence/indication of the following: injury or death to patient, evidence that a patient underwent any unnecessary medica procedure due to the reported event, physician alleging that the reported event caused him or her to provide incorrect treatment, or evidence of negative impact to the patient due to the false resistant vitek 2 result. This event is reportable as an adverse event, as the reporting of the final ast (ceftazidime) result was delayed for 24 hours. There is no indication or report from the hospital or treating physician to biomerieux that the false resistant ceftazidime result led to an adverse event related to the patient's state of health.
Patient Sequence No: 1, Text Type: D, B5